Effect of achieving bone sterilisation on bone architecture and bone marrow, in an experimental rabbit model of osteomyelitis caused by carbapenemase-producing Enterobacterales.

OBJECTIVES: Natural history and treatment of bone infections caused by carbapenemase-producing Enterobacterales (CPE) are poorly defined. We evaluated the effect of treatment on the progression of subacute osteomyelitis in a rabbit model. METHODS: Two isolates were used: a KPC-producing Klebsiella pneumoniae and an Escherichia coli harbouring blaOXA-48 and blaCTX-M15 inserts, both susceptible to gentamicin, colistin, fosfomycin, and ceftazidime-avibactam. Osteomyelitis was induced in rabbits by tibial injection of 2 × 108 colony-forming units/mL. Antibiotics were started 14 d later, for 7 d, in 6 groups of 12 rabbits. Three days after treatment completion (D24), rabbits were euthanised and bones were cultured. Bone marrow and bone architecture macroscopic changes were evaluated through analysis of pictures by investigators unaware of the rabbit treatment group and microbiological outcome, using scales ranging from 0 (normal) to 3 (severe lesions) depending on modifications. RESULTS: Bone marrow modifications induced by local infection were similar between prematurely deceased animals and non-sterilised animals (P = 0.14) but differed significantly from animals that achieved bone sterilisation after treatment (P = 0.04). Conversely, when comparing bone deformity, rabbits who died early (n = 13) had similar bone architecture as those achieving bone sterilisation (P = 0.12), as opposed to those not sterilised after treatment (P = 0.04). After a multivariate logistic regression, bone marrow scale ≤2 was associated with bone sterilisation (P < 0.001), and bone architecture scale ≤2 was associated with bone sterilisation (adjusted odds ratio = 2.7; 95% confidence interval 1.14-6.37) and KPC infection (adjusted odds ratio = 5.1; 95% confidence interval 2.17-12.13). CONCLUSION: Effective antibacterial treatment reduces bone architecture distortion and bone marrow changes. These variables may be used as proxy for bone sterilisation.

Does partial tear repair of adjacent tendons improve the outcome of supraspinatus tendonfull-thickness tear reinsertion?

BACKGROUND: Partial tearing of the infraspinatus and/or subscapularis tendon(s) is frequently associated with supraspinatus full-thickness tears. However, limited data regarding its influence on supraspinatus surgical repair is available. PURPOSE: Our aim was to assess the functional and anatomical outcomes of open repair of supraspinatus full-thickness tears combined with adjacent partial tearing, comparatively to a control. METHODS: We retrospectively identified 22 patients (22 shoulders) with a partial tear, most of them being a delamination tear, of the infraspinatus and/or subscapularis tendons associated with a complete detachment of the supraspinatus tendon. Twenty-seven patients (27 shoulders) treated for an isolated complete detachment of the supraspinatus tendon by open repair served as controls. The mean age was 58 years. A proximalized trans-osseous reinsertion of the supraspinatus tendon was combined with a curettage-closure of the delamination tear. Patients were evaluated with standardized MRI at last follow-up. RESULTS: At a mean of 75-month follow-up, the presence of a partial tear of either infraspinatus or subscapularis, or both, did not influence function and healing rates of supraspinatus tendon repair. Conversely to the control, when a retear occurred, the functional score tended to worsen. Preoperatively, fatty muscular degeneration was more pronounced when a partial tear was present. Fatty degeneration worsened regardless of repair healing. CONCLUSION: Open reinsertion of a supraspinatus full-thickness tear associated with a thorough treatment of partial tear of adjacent tendons led to optimal functional and anatomical mid term outcomes. Our results suggest the presence of a partial tear of adjacent tendons could be associated with poorer function in case of supraspinatus tendon re-rupture. LEVEL OF EVIDENCE: Level III case-control study.

Novel biological strategies for treatment of wear particle-induced periprosthetic osteolysis of orthopaedic implants for joint replacement.

Wear particles and by-products from joint replacements and other orthopaedic implants may result in a local chronic inflammatory and foreign body reaction. This may lead to persistent synovitis resulting in joint pain and swelling, periprosthetic osteolysis, implant loosening and pathologic fracture. Strategies to modulate the adverse effects of wear debris may improve the function and longevity of joint replacements and other orthopaedic implants, potentially delaying or avoiding complex revision surgical procedures. Three novel biological strategies to mitigate the chronic inflammatory reaction to orthopaedic wear particles are reported. These include (i) interference with systemic macrophage trafficking to the local implant site, (ii) modulation of macrophages from an M1 (pro-inflammatory) to an M2 (anti-inflammatory, pro-tissue healing) phenotype in the periprosthetic tissues, and (iii) local inhibition of the transcription factor nuclear factor kappa B (NF-κB) by delivery of an NF-κB decoy oligodeoxynucleotide, thereby interfering with the production of pro-inflammatory mediators. These three approaches have been shown to be viable strategies for mitigating the undesirable effects of wear particles in preclinical studies. Targeted local delivery of specific biologics may potentially extend the lifetime of orthopaedic implants.

An unreported cause of early postoperative dislocation following total hip revision: massive intra-capsular oedema related to inferior vena cava filter thrombosis.

Inferior vena cava (IVC) filters are widely used to prevent pulmonary embolism (PE) in patients with an absolute or relative contraindication for anticoagulants, during the peri-operative period of trauma or total joint replacement. No complication specific to the orthopaedic's aspect of this practice has been described. We report the case of a patient who had major femoral head/cup separation mimicking dislocation following revision total hip arthroplasty related to massive intra-capsular oedema produced by IVC filter thrombosis. The patient could be successfully treated non-operatively. Orthopaedic surgeons should identify and refer patients with a complicated IVC filter, to identify any migration or occlusion, and also be aware that removable filters must not be kept in situ, once the high-risk phase of developing PE is past.

Results of open reduction and cortico-cancellous autograft of intra-articular calcaneal fractures according to Palmer.

OBJECTIVE: To assess the mid term patient outcome after operative treatment of a displaced intra-articular calcaneal fracture using the modified Palmer technique. MATERIALS AND METHODS: Eighteen operatively treated intra-articular fractures of the calcaneus in 16 patients (nine males, seven females) were retrospectively reviewed. The mean age at surgery was 35 years (range, 17-61 years). Two patients had a bilateral fracture. Following Utheza, five fractures (28%) were classified as vertical, three as horizontal (17%) and 10 (55%) as combined. Mean preoperative Böhler angle was -4 degrees (range, -42 to 26 degrees ). An extended lateral approach to the calcaneus was used in each case. A cortical bone autograft was firmly impacted in the subthalamic void after reduction. Stabilization was achieved by two or three axial Kirschner wires and one or two screws inserted in a transverse position. Patients were evaluated at the last follow-up by physical examination and by the functional score described by Kitaoka. Böhler's angle was measured on the immediate postoperative radiographs and at the last follow-up, and compared when possible with the noninjured side. RESULTS: Follow-up ranged from 12 to 38 months (mean, 23 months). One patient required a subtalar arthrodesis for advanced osteoarthritis. One patient experienced reflex sympathetic dystrophy. No skin complication was noted. At the last follow-up evaluation, the mean Kitaoka score was 74 (range, 34-98). The functional score was considered good or excellent in 11 cases (64.7%), fair in three (17.6%), and poor in three (17.6%). The mean Böhler angle was 23.4 degrees (range, 5-40 degrees ) postoperatively and 22.7 degrees (range, 0-38 degrees ) at the last follow-up. A modest loss of correction was observed in four cases. The final Böhler angle was at least 85% compared to the healthy side in 10 cases out of 14 unilateral fractures. The functional score correlated well with restoration of Böhler's angle. DISCUSSION AND CONCLUSION: Operative treatment of intra-articular calcaneal fractures following a modified Palmer technique provided encouraging results, since restoration of Böhler's angle was obtained. The main advantages include an absence of hardware prominence, resulting in an absence of skin complications, and a stable fixation.

[Results of open reduction and cortico-cancellous autograft of intra-articular calcaneal fractures according to Palmer]. / Résultats du traitement des fractures articulaires du calcaneus par relèvement à foyer ouvert et greffe systématique selon la méthode de Palmer. A propos de 18 cas.

OBJECTIVE: To assess the mid-term patient outcome after operative treatment of a displaced intra-articular calcaneal fracture according to Palmer. MATERIALS AND METHODS: Eighteen operatively treated intra-articular fractures of the calcaneus in 16 patients (nine males, seven females) were retrospectively reviewed. Mean age at surgery was 35 years (range, 17-61 years). Two patients had a bilateral fracture. According to Rev Chir Orthop 79 (1993) 49-57, five fractures (28 percent) were classified as vertical, three as horizontal (17 percent), and 10 (55 percent) as combined. Mean preoperative Böhler angle was -4 degrees (range, -42-26 degrees ). An extended lateral approach to the calcaneus was used in each case. A cortical bone autograft was firmly impacted in the sub thalamic void after reduction. Stabilization was achieved by two or three axial Kirschner wires and one or two screw(s) inserted in a transverse position. Patients were evaluated at the last follow-up by physical examination and by the functional score described by Foot Ankle Int 15 (1994) 349-353. Böhler's angle was measured on the immediate postoperative radiographs and at the last follow-up, and compared when possible with the noninjured side. RESULTS: Follow-up ranged from 12 to 38 months (average, 23 months). One patient (one calcaneus) required a subtalar arthrodesis for advanced osteoarthritis. One patient (one calcaneus) experienced reflex sympathetic dystrophy. No skin complication was noted. At the last follow-up evaluation, mean Kitaoka score was 74 (range, 34-98). Functional score was considered good or excellent in 11 cases (64.7 percent), fair in three (17.6 percent) and poor in three (17.6 percent). Mean Böhler angle was 23.4 degrees (range, 5-40 degrees ) postoperatively and 22.7 degrees (range, 0-38 degrees ) at the last follow-up. A modest loss of correction was observed in four cases. Final Böhler angle was at least 85 percent comparatively to the healthy side in 10 cases among 14 unilateral fractures. Functional score correlated well with restoration of Böhler's angle. DISCUSSION AND CONCLUSION: Operative treatment of intra-articular calcaneal fractures according to Palmer provided encouraging results, since restoration of Böhler's angle was obtained. Main advantages include an absence of hardware prominence, resulting in an absence of skin complication, and a stable fixation.

[Femoral reconstruction with impacted macroporous calcium phosphate ceramic in revision hip arthroplasty]. / Reconstruction fémorale par céramique de phosphate de calcium macroporeuse impactée au cours des reprises d'arthroplastie de hanche.

PURPOSE OF THE STUDY: Management of bone stock loss remains one of the most challenging problems for revision hip surgery. The aim of this retrospective study was to report the preliminary results of peri-prosthetic femoral defect reconstruction with impacted granules of calcium phosphate ceramic. MATERIAL AND METHODS: Fourteen hips in 13 patients (3 men and 10 women) were evaluated. Age at surgery ranged from 30 to 79 years (mean 66.1 years). All revised devices had been cemented. Femoral revision was indicated for loosening in eleven hips (including six septic cases), femoral osteolysis (one hip), persistent pain (one hip), and recurrent dislocation (one hip). On the preoperative radiological evaluation, bone defects were assessed as SOFCOT grade II in seven case, and grade III in fourteen. None was rated grade IV. Once the loose prosthesis had been removed, bone graft or ceramic granules (14 cases) were firmly impacted in the femoral canal. The stem was standard and always cemented using modern cementing technique. RESULTS: At a mean follow-up of 34 +/- 15 months (range 14-76 months), eleven of fourteen hips were rated good or very good according to the Postel-Merle-d'Aubigné score. One diaphyseal femoral fracture occurred and later united. Two hips required re-revision (one aseptic femoral loosening, one septic recurrence). Direct bonding between synthetic graft and bone was observed on standard radiographs in eleven cases. Stem subsidence occurred in two cases and was limited (mean 4.5 mm). DISCUSSION: Femoral bone reconstruction using impacted calcium phosphate ceramic in revision hip arthroplasty provided encouraging results in the short to mid term. Femoral stock restoration was achieved in the great majority. No adverse effect related to the use of a synthetic graft was noted. Further long-term evaluation is required before wider application.

Bone substitution in revision hip replacement.

The aim of this retrospective study was to report the preliminary results of femoral peri-prosthetic bone defect reconstruction with a synthetic bone substitute. Twenty-one revisions of the femoral component in 20 patients were evaluated. The mean age at operation was 65.7 years (range, 30 to 79 years). Preoperative femoral deficiencies were rated grade II in 7 cases and grade III in 14 cases according to the SOFCOT classification. None was rated grade IV. Femoral revision was indicated for loosening in 18 hips (including 8 septic cases), femoral osteolysis (1 hip), persistent pain (1 hip) and recurrent dislocation (1 hip). Once the loose prosthesis had been removed, calcium phosphate ceramic (CPC) granules (14 cases) or ceramic granules + cancellous allograft (5 cases) or autograft (2) were firmly impacted in the femoral canal. The stem was standard and always cemented using modern cementing technique. At a mean follow-up of 36 months (range, 14 to 76 months), 90% of the hips were rated good or very good according to the Merle d'Aubigné score. Two diaphyseal femoral fractures occurred and later united. Two hips required re-revision (aseptic loosening; septic recurrence). The absence of radiological osteolysis in 17 cases suggested direct bonding between ceramic granules and bone. Stem subsidence occurred in two cases and was limited (5 and 8 mm). Femoral bone reconstruction using impacted CPC or CPC in conjunction with bone graft in revision hip replacement commonly provided restoration of the bone stock in the short to mid-term. Further long-term studies will be necessary to support this conclusion.

[Metal-metal-backed polyethylene cemented hip arthroplasty: mid-term results]. / Arthroplastie de hanche a couple métal-metal sur polyéthylène cimenté: Résultats a moyen terme.

PURPOSE OF THE STUDY: Metal-on-metal bearings in total hip arthroplasty may, in theory, provide an effective answer to osteolysis in active patients. The purpose of this retrospective study was to evaluate the results of a consecutive series of Metasul total hip arthroplasties with a cemented socket. MATERIAL AND METHODS: The series was composed of 28 total hip arthroplasties in 23 patients (13 women and 10 men). The mean age at operation was 44 +/- 8.3 years (range 22-59 years). The initial diagnosis was osteoarthritis (14 hips), osteonecrosis of the femoral head (11 hips) and rheumatoid arthritis (3 hips). Cemented cups with a metal articulation surface molded into the polyethylene were used. The cup was articulated with a 28-mm metallic head. Cemented stems were used in 27 hips, whereas a hydroxyapatite coated stem was implanted in one hip. RESULTS: One hip required revision for deep infection five months postoperatively. One patient (one hip) was lost to follow-up. Twenty-six hips were evaluated at an average 31-month follow-up (range 12-47 months). All hips were rated excellent or very good. Radiographically, seven hips (27%) had a progressive acetabular radiolucent line, including three complete radiolucent lines. The latter always were located at the bone-cement interface. No implant migration was noted. In these cases, the mean socket diameter was lower than for the rest of the cohort (p < 0.001). DISCUSSION AND CONCLUSION: Progression of acetabular radiolucent lines remains of concern in this series of Metasul artificial hips. It is hypothesized that the diminution of polyethylene thickness has led to an increased rigidity of the socket, resulting in a higher rate of constraints at the bone-cement interface. Special attention must be given to these hips.

[An uncommon form of delayed radio-induced brachial plexopathy]. / Une forme inhabituelle de plexopathie brachiale radio-induite tardive.

Radiation therapy of the neck or axillary areas for cancer may result in delayed brachial plexus palsy. Differential diagnosis between radiation and tumor brachial plexopathy is difficult. We report the case of a 38-year-old woman, treated by radiation therapy for osteosarcoma of the humeral head 22 years before, who exhibited a rapidly progressive incomplete hand palsy. EMG study revealed a conduction block at the level of the lateral cord. In this case, MRI could not distinguish between a delayed radiation injury and tumor infiltration. The diagnosis was clarified with an ultrasonographic examination. Neurolysis and epineurotomy of the median trunk in the brachial and axillary areas were performed. Histological examination confirmed radiation-induced nerve injury. The characteristics of this uncommon form are reviewed with regard to the previously reported descriptions.

Perspective is everything: the predictive validity of six working alliance instruments.

The predictive validity of instruments commonly used to measure the therapeutic alliance was evaluated, using 46 sessions drawn from a clinical trial comparing manual-guided therapies for substance use. The California Psychotherapy Alliance Scale, Penn Helping Alliance Rating Scale, Vanderbilt Therapeutic Alliance Scale, and Working Alliance Inventory (Observer, Therapist, and Client versions) were rated for participants receiving either cognitive-behavioral therapy or twelve-step facilitation. All observer-rated instruments were significantly correlated with outcome; however, therapist-rated and client-rated instruments did not predict outcome. Findings suggest that the different observer-rated instruments are minimally different with respect to predictive validity, whereas patient- and therapist-rated measures may have a weaker relationship to outcome when highly objective outcome measures are used.

Targeting behavioral therapies to enhance naltrexone treatment of opioid dependence: efficacy of contingency management and significant other involvement.

BACKGROUND: Contingency management (CM) and significant other involvement (SO) were evaluated as strategies to enhance treatment retention, medication compliance, and outcome for naltrexone treatment of opioid dependence. METHODS: One hundred twenty-seven recently detoxified opioid-dependent individuals were randomly assigned to 1 of 3 conditions delivered for 12 weeks: (1) standard naltrexone treatment, given 3 times a week; (2) naltrexone treatment plus contingency management (CM), with delivery of vouchers contingent on naltrexone compliance and drug-free urine specimens; or (3) naltrexone treatment, CM, plus significant other involvement (SO), where a family member was invited to participate in up to 6 family counseling sessions. Principal outcomes were retention in treatment, compliance with naltrexone therapy, and number of drug-free urine specimens. RESULTS: First, CM was associated with significant improvements in treatment retention (7.4 vs 5.6 weeks; P =.05) and in reduction in opioid use (19 vs 14 opioid-free urine specimens; P =.04) compared with standard naltrexone treatment. Second, assignment to SO did not significantly improve retention, compliance, or substance abuse outcomes compared with CM. Significant effects for the SO condition over CM on retention, compliance, and drug use outcomes were seen only for the subgroup who attended at least 1 family counseling session. The SO condition was associated with significant (P =.02) improvements in family functioning. CONCLUSION: Behavioral therapies, such as CM, can be targeted to address weaknesses of specific pharmacotherapies, such as noncompliance, and thus can play a substantial role in broadening the utility of available pharmacotherapies.

One-year follow-up of disulfiram and psychotherapy for cocaine-alcohol users: sustained effects of treatment.

AIM: To evaluate outcomes 1 year after cessation of treatment for cocaine- and alcohol-dependent individuals. DESIGN: Randomized controlled trial. SETTING: Urban substance abuse treatment center. PARTICIPANTS: Ninety-six of 122 subjects randomized to treatment. INTERVENTIONS: One of five treatments delivered over 12 weeks. Cognitive-behavioral treatment (CBT) plus disulfiram; Twelve-Step facilitation (TSF) plus disulfiram; clinical management (CM) plus disulfiram; CBT without disulfiram; TSF without disulfiram. MEASUREMENTS: Percentage of days of cocaine and alcohol use during follow-up, verified by urine toxicology screens and breathalyzer tests. RESULTS: First, as a group, participants reported significant decreases in frequency of cocaine, but not alcohol, use after the end of treatment. Secondly, the main effects of disulfiram on cocaine and alcohol use were sustained during follow-up. Finally, initiation of abstinence for even brief periods of time within treatment was associated with significantly better outcome during follow-up. CONCLUSIONS: These findings support the efficacy of disulfiram with this challenging population and suggest that comparatively brief treatments that facilitate the initiation of abstinence may have long-term benefits.

Disulfiram treatment for cocaine dependence in methadone-maintained opioid addicts.

AIMS: Cocaine use by patients on methadone maintenance treatment is a widespread problem and is associated with a poorer prognosis. Recent studies have evaluated disulfiram as a treatment for individuals with comorbid alcohol and cocaine abuse. We evaluated the efficacy of disulfiram for cocaine dependence, both with and without co-morbid alcohol abuse, in a group of methadone-maintained opioid addicts. DESIGN: Randomized double-blind, placebo-controlled trial. SETTING: Urban methadone maintenance clinic. PARTICIPANTS: Sixty-seven cocaine-dependent, methadone-maintained, opioid-dependent subjects (52% female; 51% Caucasian). INTERVENTION: Study medication, either disulfiram or placebo, was placed directly in the methadone to ensure compliance for 12 weeks. MEASUREMENTS: Primary outcome measures included weekly assessments of the frequency and quantity of drug and alcohol use, weekly urine toxicology screens and breathalyzer readings. FINDINGS: Disulfiram treated subjects decreased the quantity and frequency of cocaine use significantly more than those treated with placebo. Alcohol use was minimal for all subjects regardless of the medication. CONCLUSIONS: Disulfiram may be an effective pharmacotherapy for cocaine abuse among methadone-maintained opioid addicts, even in those individuals without co-morbid alcohol abuse. Disulfiram inhibits dopamine beta-hydroxylase resulting in an excess of dopamine and decreased synthesis of norepinephrine. Since cocaine is a potent catecholamine re-uptake inhibitor, disulfiram may blunt cocaine craving or alter the "high", resulting in a decreased desire to use cocaine.

A general system for evaluating therapist adherence and competence in psychotherapy research in the addictions.

The Yale Adherence and Competence Scale (YACS) is a general system for rating therapist adherence and competence in delivering behavioral treatments for substance use disorders. The system includes three scales measuring 'general' aspects of drug abuse treatment (assessment, general support, goals of treatment), as well as three scales measuring critical elements of three treatments that are frequently implemented as control or comparison treatments in clinical research in the addictions (clinical management (CM), twelve step facilitation (TSF), and cognitive behavioral therapy (CBT)). Validation of the YACS using data from a randomized clinical trial indicated that the scales have excellent reliability, factor structure, concurrent and discriminant validity. Correlations between adherence and competence scores within scales were in the moderate range, indicating independence (and thus nonredundancy) of these dimensions. Strategies for using the YACS in both psychotherapy and pharmacotherapy research in the addictions are described.

'Research' versus 'real-world' patients: representativeness of participants in clinical trials of treatments for cocaine dependence.

Rigorous clinical trials have been criticized as having limited external validity, and specifically that subjects participating in clinical trials are not representative of individuals seen in clinical practice. To assess the representativeness of subjects participating in clinical trials, 243 research subjects participating in clinical trials of treatments for cocaine dependence were compared to a sub-sample of 213 individuals being treated for cocaine dependence in outpatient clinical settings from a large national database. The data suggest that research findings are not invariably based on less challenging patients with mild forms of substance dependence and related problems; moreover research patients may be similar to, if not more severe than, individuals with cocaine problems seen in regular clinical settings in the community.

Treatment of cocaine and alcohol dependence with psychotherapy and disulfiram.

AIMS: To evaluate disulfiram and three forms of manual guided psychotherapy for individuals with cocaine dependence and concurrent alcohol abuse or dependence. DESIGN: Randomized controlled trial. SETTING: Urban substance abuse treatment center. PARTICIPANTS: One hundred and twenty-two cocaine/alcohol abusers (27% female; 61% African-American or Hispanic). INTERVENTIONS: One of five treatments delivered over 12 weeks: cognitive behavioral treatment (CBT) plus disulfiram; Twelve Step facilitation (TSF) plus disulfiram; clinical management (CM) plus disulfiram; CBT plus no medication; TSF plus no medication. MEASUREMENTS: Duration of continuous abstinence from cocaine or alcohol; frequency and quantity of cocaine and alcohol use by week, verified by urine toxicology and breathalyzer screens. FINDINGS: Disulfiram treatment was associated with significantly better retention in treatment, as well as longer duration of abstinence from alcohol and cocaine use. The two active psychotherapies (CBT and TSF) were associated with reduced cocaine use over time compared with supportive psychotherapy (CM). Cocaine and alcohol use were strongly related throughout treatment, particularly for subjects treated with disulfiram. CONCLUSIONS: For the large proportion of cocaine-dependent individuals who also abuse alcohol, disulfiram combined with outpatient psychotherapy may be a promising treatment strategy. This study underlines (a) the significance of alcohol use among treatment-seeking cocaine abusers, (b) the promise of the strategy of treating co-morbid disorders among drug-dependent individuals, and (c) the importance of combining psychotherapy and pharmacotherapy in the treatment of drug use disorders.

Fluoxetine treatment of depressive disorders in methadone-maintained opioid addicts.

This study tested the effectiveness of fluoxetine as a treatment for depression in a population of methadone-maintained opioid addicts. Methadone-maintained opioid addicts (44) with depression received fluoxetine or placebo in addition to their methadone, in a double-blind randomized trial, for 12 weeks. Depressive symptoms decreased significantly overall with no significant differences between the groups treated with fluoxetine versus placebo. In addition, drug use outcomes, including cocaine and heroin self-reported use and urine toxicology were measured. There was a significant decrease in heroin use in treatment, but no medication effect. Cocaine use, was unchanged from pre-treatment to endpoint. In separately analyzing data for the subsample of subjects with the most severe depression, there was a significant decrease in depression during treatment and a significant decrease in self-reported cocaine use, but no medication effect on either depressive symptoms or on cocaine use. This study suggests that fluoxetine is not an effective agent in treating depression or cocaine use in this population.

Contribution of the therapeutic alliance to outcome in active versus control psychotherapies.

Few studies have examined the role of the therapeutic alliance scores in active versus control psychotherapies. Using data from a randomized clinical trial of psychotherapy and pharmacotherapy for cocaine dependence, it was found that therapeutic alliance scores were rated as significantly more positive in cognitive-behavioral treatment than clinical management, a psychotherapy control condition. However, level of the therapeutic alliance was associated with outcome for the control but not the active psychotherapy. These data suggest that control conditions, which are intended to control for common factors of psychotherapies such as the therapeutic alliance, may exert their effect on outcomes primarily through the level of those common factors.