Predictors of outcome for short-term medically supervised opioid withdrawal during a randomized, multicenter trial of buprenorphine-naloxone and clonidine in the NIDA clinical trials network drug and alcohol dependence.

Few studies in community settings have evaluated predictors, mediators, and moderators of treatment success for medically supervised opioid withdrawal treatment. This report presents new findings about these factors from a study of 344 opioid-dependent men and women prospectively randomized to either buprenorphine-naloxone or clonidine in an open-label 13-day medically supervised withdrawal study. Subjects were either inpatient or outpatient in community treatment settings; however not randomized by treatment setting. Medication type (buprenorphine-naloxone versus clonidine) was the single best predictor of treatment retention and treatment success, regardless of treatment setting. Compared to the outpatient setting, the inpatient setting was associated with higher abstinence rates but similar retention rates when adjusting for medication type. Early opioid withdrawal severity mediated the relationship between medication type and treatment outcome with buprenorphine-naloxone being superior to clonidine at relieving early withdrawal symptoms. Inpatient subjects on clonidine with lower withdrawal scores at baseline did better than those with higher withdrawal scores; inpatient subjects receiving buprenorphine-naloxone did better with higher withdrawal scores at baseline than those with lower withdrawal scores. No relationship was found between treatment outcome and age, gender, race, education, employment, marital status, legal problems, baseline depression, or length/severity of drug use. Tobacco use was associated with worse opioid treatment outcomes. Severe baseline anxiety symptoms doubled treatment success. Medication type (buprenorphine-naloxone) was the most important predictor of positive outcome; however the paper also considers other clinical and policy implications of other results, including that inpatient setting predicted better outcomes and moderated medication outcomes.

A multi-center randomized trial of buprenorphine-naloxone versus clonidine for opioid detoxification: findings from the National Institute on Drug Abuse Clinical Trials Network.

AIMS: The clinical effectiveness of buprenorphine-naloxone (bup-nx) and clonidine for opioid detoxification in in-patient and out-patient community treatment programs was investigated in the first studies of the National Institute of Drug Abuse Clinical Trials Network. DESIGN: Diagnostic and Statistical Manual version IV (DSM IV)-diagnosed opioid-dependent individuals seeking short-term treatment were randomly assigned, in a 2 : 1 ratio favoring bup-nx, to a 13-day detoxification using bup-nx or clonidine. METHODS: A total of 113 in-patients (77 bup-nx, 36 clonidine) and 231 out-patients (157 bup-nx, 74 clonidine) participated. Supportive interventions included appropriate ancillary medications and standard counseling procedures guided by a self-help handbook. The criterion for treatment success was defined as the proportion of participants in each condition who were both retained in the study for the entire duration and provided an opioid-free urine sample on the last day of clinic attendance. Secondary outcome measures included use of ancillary medications, number of side effects reported and withdrawal and craving ratings. FINDINGS: A total of 59 of the 77 (77%) in-patients assigned to the bup-nx condition achieved the treatment success criterion compared to eight of the 36 (22%) assigned to clonidine, whereas 46 of the 157 (29%) out-patients assigned to the bup-nx condition achieved the treatment success criterion, compared to four of the 74 (5%) assigned to clonidine. CONCLUSION: The benefits of bup-nx for opioid detoxification are supported and illustrate important ways in which clinical research can be conducted in community treatment programs.

Bringing buprenorphine-naloxone detoxification to community treatment providers: the NIDA Clinical Trials Network field experience.

In October 2002, the U.S. Food and Drug Administration approved buprenorphine-naloxone (Suboxone) sublingual tablets as an opioid dependence treatment available for use outside traditionally licensed opioid treatment programs. The NIDA Center for Clinical Trials Network (CTN) sponsored two clinical trials assessing buprenorphine-naloxone for short-term opioid detoxification. These trials provided an unprecedented field test of its use in twelve diverse community-based treatment programs. Opioid-dependent men and women were randomized to a thirteen-day buprenorphine-naloxone taper regimen for short-term opioid detoxification. The 234 buprenorphine-naloxone patients averaged 37 years old and used mostly intravenous heroin. Direct and rapid induction onto buprenorphine-naloxone was safe and well tolerated. Most patients (83%) received 8 mg buprenorphine-2 mg naloxone on the first day and 90% successfully completed induction and reached a target dose of 16 mg buprenorphine-4 mg naloxone in three days. Medication compliance and treatment engagement was high. An average of 81% of available doses was ingested, and 68% of patients completed the detoxification. Most (80.3%) patients received some ancillary medications with an average of 2.3 withdrawal symptoms treated. The safety profile of buprenorphine-naloxone was excellent. Of eighteen serious adverse events reported, only one was possibly related to buprenorphine-naloxone. All providers successfully integrated buprenorphine-naloxone into their existing treatment milieus. Overall, data from the CTN field experience suggest that buprenorphine-naloxone is practical and safe for use in diverse community treatment settings, including those with minimal experience providing opioid-based pharmacotherapy and/or medical detoxification for opioid dependence.

Characteristics and problems of 600 adolescent cannabis abusers in outpatient treatment.

AIMS: Risk factors among adolescent substance abusers have been shown to correlate with substance use severity. Characteristics related to severity, such as demographic and family factors, peer influences, psychiatric co-morbidity and HIV risk behaviors, are examined for a sample of adolescent cannabis users entering treatment. DESIGN: These data are from a clinical trial study utilizing blocked random assignment of clients to one of five treatment conditions. The study targeted adolescents entering outpatient treatment for primarily cannabis abuse or dependence. SETTING: Treatment and research facilities in four metropolitan areas of the US were used to recruit study participants. Treatment was delivered in outpatient drug-free settings. PARTICIPANTS: Participants were 600 clients, ages 12-18, admitted to outpatient substance abuse treatment programs for cannabis problems, 96% with DSM-IV diagnoses of substance abuse or dependence, with the remaining 4% having at least one symptom of dependence plus significant problems indicating need for treatment. MEASUREMENTS: The Global Appraisal of Individual Needs (GAIN) was used to collect the information presented in this paper. The GAIN incorporates DSM-IV criteria for substance use disorders, conduct disorder and attention deficit hyperactivity disorder, as well as dimensional (scale) measures for physical and mental health. FINDINGS: All participants reported at least one symptom of substance use disorders, and 46% met the DSM-IV criteria for substance dependence, while 50% met criteria for a diagnosis of abuse. Only 20% of the participants perceived any need for help with problems associated with their drug or alcohol use. Clients participating in the study typically presented multiple problems at treatment entry, most often including conduct disorder, attention deficit hyperactivity disorder (ADHD), internal (mental) distress, and physical health distress. The co-occurrence of conduct disorder and ADHD was found in 30% of the sample. Clients meeting criteria for substance dependence tended to have more co-occurring problems and significantly less denial at admission. CONCLUSIONS: The characteristics of this sample exemplify the complex nature of adolescent substance use and abuse among adolescents entering outpatient treatment programs. Patterns of co-occurring problems are at rates comparable to those found in other clinical studies. Those with more severe substance use disorders tend to manifest more problems of social functioning, more mental health problems, and physical health problems. Implications of these findings are discussed in terms of treatment needs, challenges, and prognostic implications.

Cannabis use: consistency and validity of self-report, on-site urine testing and laboratory testing.

AIMS: To evaluate the agreement between adolescent self-reported cannabis use, "on-site" qualitative urine screening, and quantitative laboratory testing. DESIGN: A cross-sectional study of intake and follow-up data from 248 adolescents entering substance abuse treatment for cannabis use disorders (abuse or dependence). This is part of the multi-site cooperative agreement Cannabis Youth Treatment study. SETTING: Data collected from adolescents randomly assigned to one of five outpatient treatments at four sites: Operation PAR, Inc., Florida; Chestnut Health Systems, Illinois; University of Connecticut Health Center, Connecticut; and Children's Hospital of Philadelphia, Pennsylvania. PARTICIPANTS: The data represent 248 unique individuals from a sample of 297 adolescents ranging in age from 12 to 18 years. MEASUREMENTS: Prevalence, agreement, kappa, sensitivity, specificity, positive and negative predictive value. FINDINGS: The self-report rates were higher at intake than either urine test (82.4% vs. 77.0% vs. 52.7%), but both lower and higher at the 3-month follow-up (55.5% vs. 70.0% vs. 47.3%) and 6-month follow-up (60.2% vs. 73.5% vs. 55.8%). The disagreements went in both directions and the kappa coefficients were only in the moderate range (0.4). Over two-thirds of these frequent cannabis users tested positive when they said they had not used in 1 week and one-third tested positive even though they said it had been more than 4 weeks since last use. CONCLUSIONS: The findings suggest both the advantages of multiple sources of information and the need for further work on the latency of cannabis metabolites in clinical populations.