Extended-Release Injectable Naltrexone (XR-NTX) With Intensive Psychosocial Therapy for Amphetamine-Dependent Persons Seeking Treatment: A Placebo-Controlled Trial.

OBJECTIVE: Explore the efficacy of extended-release injectable naltrexone (XR-NTX) for preventing relapse to amphetamine use. METHOD: Clinical trial of 100 amphetamine-dependent, treatment-seeking patients who were randomized to 6 monthly 380 mg doses of XR-NTX or matching placebo before entering intensive outpatient after varying lengths of inpatient treatment in Reykjavik, Iceland. Weekly urine drug tests, retention, and standardized instruments assessed efficacy. RESULTS: Of 169 approached, 100 were randomized. Although amphetamine dependence was the main reason for seeking treatment, three-quarters or more of participants had 1 or more other substance dependencies. Of 51 randomized to XR-NTX, 20 received 4 or more injections; of 49 assigned to placebo, 26 received 4 or more injections. Of the planned 2400 weekly urine drug tests, 1247 were collected (52%); 4% of these were positive for amphetamine, 8% for benzodiazepine, 7% for marijuana, 1% for cocaine, and 1% for opioid. XR-NTX had no effect on amphetamine-positive tests, retention, or other outcomes. Those providing half or more of their tests attended more weeks of treatment than those providing less than half of their tests (m = 10.76 vs 3.31; t (92) = 5.91, P < 0.0001), and 92 participants provided at least 1 test. CONCLUSIONS: Adding XR-NTX to the usual combination of inpatient and intensive outpatient treatment did not reduce amphetamine use. The low prevalence of substance use among collected urine samples, and the association between collected samples and weeks in treatment, was consistent with other studies showing that staying in treatment is associated with better outcomes.

Factors contributing to dropping out from and returning to HIV treatment in an inner city primary care HIV clinic in the United States.

Although advances in pharmacotherapy have enabled people living with HIV/AIDS to live longer, fuller lives, some leave medical care, resulting in sub-optimal treatment and increased health risk to themselves and others. Forty-one patients who dropped out of an urban, publically funded primary care HIV clinic were contacted and encouraged by outreach staff to return. Participants were interviewed within two weeks of returning, and themes associated with dropping out and returning were elicited and content analyzed. Dropping out was associated with drug/alcohol use, unstable housing/homelessness, psychiatric disorders, incarceration, problems with HIV medications, inability to accept the diagnosis, relocation, stigma, problems with the clinic, and forgetfulness. Returning was associated with health concerns, substance abuse treatment/recovery, stable housing, incarceration/release, positive feelings about the clinic, spirituality, and assistance from family/relocation. Because a large number of patients reported substance abuse, depression, and past suicide attempts. Clinic staff should assess substance use, depression, and suicidal ideation at each primary care visit and encourage patients to obtain substance abuse treatment and mental health care. Future interventions could include providing SBIRT and/or onsite mental health and substance abuse treatment, all of which may boost retention.

Randomized controlled trial of osmotic-release methylphenidate with cognitive-behavioral therapy in adolescents with attention-deficit/hyperactivity disorder and substance use disorders.

OBJECTIVE: To evaluate the efficacy and safety of osmotic-release methylphenidate (OROS-MPH) compared with placebo for attention-deficit/hyperactivity disorder (ADHD), and the impact on substance treatment outcomes in adolescents concurrently receiving cognitive-behavioral therapy (CBT) for substance use disorders (SUD). METHOD: This was a 16-week, randomized, controlled, multi-site trial of OROS-MPH + CBT versus placebo + CBT in 303 adolescents (aged 13 through 18 years) meeting DSM-IV diagnostic criteria for ADHD and SUD. Primary outcome measures included the following: for ADHD, clinician-administered ADHD Rating Scale (ADHD-RS), adolescent informant; for substance use, adolescent-reported days of use in the past 28 days. Secondary outcome measures included parent ADHD-RS and weekly urine drug screens (UDS). RESULTS: There were no group differences on reduction in ADHD-RS scores (OROS-MPH: -19.2, 95% confidence interval [CI], -17.1 to -21.2; placebo, -21.2, 95% CI, -19.1 to -23.2) or reduction in days of substance use (OROS-MPH: -5.7 days, 95% CI, 4.0-7.4; placebo: -5.2 days, 95% CI, 3.5-7.0). Some secondary outcomes favored OROS-MPH, including lower parent ADHD-RS scores at 8 (mean difference = 4.4, 95% CI, 0.8-7.9) and 16 weeks (mean difference =6.9; 95% CI, 2.9-10.9) and more negative UDS in OROS-MPH (mean = 3.8) compared with placebo (mean = 2.8; p = .04). CONCLUSIONS: OROS-MPH did not show greater efficacy than placebo for ADHD or on reduction in substance use in adolescents concurrently receiving individual CBT for co-occurring SUD. However, OROS-MPH was relatively well tolerated and was associated with modestly greater clinical improvement on some secondary ADHD and substance outcome measures. Clinical Trial Registration Information-Attention Deficit Hyperactivity Disorder (ADHD) in Adolescents with Substance Use Disorders (SUD); http://www.clinicaltrials.gov; NCT00264797.

Effects of lower-cost incentives on stimulant abstinence in methadone maintenance treatment: a National Drug Abuse Treatment Clinical Trials Network study.

BACKGROUND: Contingency management interventions that provide tangible incentives based on objective indicators of drug abstinence have improved treatment outcomes of substance abusers, but have not been widely implemented in community drug abuse treatment settings. OBJECTIVE: To compare outcomes achieved when a lower-cost prize-based contingency management treatment is added to usual care in community methadone hydrochloride maintenance treatment settings. DESIGN: Random assignment to usual care with (n = 198) or without (n = 190) abstinence incentives during a 12-week trial. SETTING: Six community-based methadone maintenance drug abuse treatment clinics in locations across the United States. PARTICIPANTS: Three hundred eighty-eight stimulant-abusing patients enrolled in methadone maintenance programs for at least 1 month and no more than 3 years. INTERVENTION: Participants submitting stimulant- and alcohol-negative samples earned draws for a chance to win prizes; the number of draws earned increased with continuous abstinence time. MAIN OUTCOME MEASURES: Total number of stimulant- and alcohol-negative samples provided, percentage of stimulant- and alcohol-negative samples provided, longest duration of abstinence, retention, and counseling attendance. RESULTS: Submission of stimulant- and alcohol-negative samples was twice as likely for incentive as for usual care group participants (odds ratio, 1.98; 95% confidence interval, 1.42-2.77). Achieving 4 or more, 8 or more, and 12 weeks of continuous abstinence was approximately 3, 9, and 11 times more likely, respectively, for incentive vs usual care participants. Groups did not differ on study retention or counseling attendance. The average cost of prizes was 120 dollars per participant. CONCLUSION: An abstinence incentive approach that paid 120 dollars in prizes per participant effectively increased stimulant abstinence in community-based methadone maintenance treatment clinics.

Effect of prize-based incentives on outcomes in stimulant abusers in outpatient psychosocial treatment programs: a national drug abuse treatment clinical trials network study.

CONTEXT: Contingency management interventions that provide tangible incentives based on objective indicators of drug abstinence are efficacious in improving outcomes in substance abusers, but these treatments have rarely been implemented in community-based settings. OBJECTIVE: To evaluate the efficacy of an abstinence-based contingency management intervention as an addition to usual care in community treatment settings. DESIGN: Random assignment to usual care or usual care plus abstinence-based incentives for 12 weeks. SETTING: Eight community-based outpatient psychosocial drug abuse treatment programs. PARTICIPANTS: A total of 415 cocaine or methamphetamine users beginning outpatient substance abuse treatment. INTERVENTION: All participants received standard care, and those assigned to the abstinence-based incentive condition also earned chances to win prizes for submitting substance-free urine samples; the chances of winning prizes increased with continuous time abstinent. MAIN OUTCOME MEASURES: Retention, counseling attendance, total number of substance-free samples provided, percentage of stimulant- and alcohol-free samples submitted, and longest duration of confirmed stimulant abstinence. RESULTS: Participants assigned to the abstinence-based incentive condition remained in treatment for a mean +/- SD of 8.0 +/- 4.2 weeks and attended a mean +/- SD of 19.2 +/- 16.8 counseling sessions compared with 6.9 +/- 4.4 weeks and 15.7 +/- 14.4 sessions for those assigned to the usual care condition (P<.02 for all). Participants in the abstinence-based incentive condition also submitted significantly more stimulant- and alcohol-free samples (P<.001). The abstinence-based incentive group was significantly more likely to achieve 4, 8, and 12 weeks of continuous abstinence than the control group, with odds ratios of 2.5, 2.7, and 4.5, respectively. However, the percentage of positive samples submitted was low overall and did not differ between conditions. CONCLUSION: The abstinence-based incentive procedure, which provided a mean of 203 dollars in prizes per participant, was efficacious in improving retention and associated abstinence outcomes.

Staff beliefs about drug abuse clinical trials.

Staff from 10 community-based addiction treatment organizations in the National Drug Abuse Clinical Trials Network participated in an educational session about addiction research practices and human subject protections. This 1.5-hour presentation addressed "informed consent," "confidentiality of research information," "inclusion and exclusion criteria," "random assignment," "patient protections," and "patient payments." Pre- and postsession surveys were administered to 115 staff members measuring their beliefs about clinical trials. At baseline, 52% of staff believed patients could transfer out of a study even if they were doing poorly, and 55% believed staff had this right; 44% agreed that patients could participate in a clinical trial without understanding what would take place in the study. After the educational session, staff beliefs about patient protections were significantly increased in five of the seven items. A fourth of staff continued to believe patient payments were harmful, and 37% did not believe participation in a clinical trial would increase a patient's chances at recovery.