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Aims To examine the safety and effectiveness of buprenorphine + naloxone sublingual tablets (BUP, as Suboxone(®) ) provided after administration of extended-release injectable naltrexone (XR-NTX, as Vivitrol(®) ) to reduce cocaine use in participants who met DSM-IV criteria for cocaine dependence and past or current opioid dependence or abuse. Methods This multi-centered, double-blind, placebo-controlled study, conducted under the auspices of the National Drug Abuse Treatment Clinical Trials Network, randomly assigned 302 participants at sites in California, Oregon, Washington, Colorado, Texas, Georgia, Ohio, New York and Washington DC, USA to one of three conditions provided with XR-NTX: 4 mg/day BUP (BUP4, n = 100), 16 mg/day BUP (BUP16, n = 100, or no buprenorphine (placebo; PLB, n = 102). Participants received pharmacotherapy for 8 weeks, with three clinic visits per week. Cognitive behavioral therapy was provided weekly. Follow-up assessments occurred at 1 and 3 months post-intervention. The planned primary outcome was urine drug screen (UDS)-corrected, self-reported cocaine use during the last 4 weeks of treatment. Planned secondary analyses assessed cocaine use by UDS, medication adherence, retention and adverse events. Results No group differences were found between groups for the primary outcome (BUP4 versus PLB, P = 0.262; BUP16 versus PLB, P = 0.185). Longitudinal analysis of UDS data during the evaluation period using generalized linear mixed equations found a statistically significant difference between BUP16 and PLB [P = 0.022, odds ratio (OR) = 1.71] but not for BUP4 (P = 0.105, OR = 1.05). No secondary outcome differences across groups were found for adherence, retention or adverse events. Conclusions Buprenorphine + naloxone, used in combination with naltrexone, may be associated with reductions in cocaine use among people who meet DSM-IV criteria for cocaine dependence and past or current opioid dependence or abuse.

Background and Objectives Induction is a crucial period of opioid addiction treatment. This study aimed to identify buprenorphine/naloxone (BUP) induction patterns and examine their association with outcomes (opioid use, retention, and related adverse events [AEs]). Methods The secondary analysis of a study of opioid-dependent adults seeking treatment in eight treatment settings included 740 participants inducted on BUP with flexible dosing. Results Latent class analysis models detected six distinctive induction trajectories: bup1-started and remained on low; bup2-started low, shifted slowly to moderate; bup3-started low, shifted quickly to moderate; bup4-started high, shifted to low; bup5-started and remained on moderate; bup6-started moderate, shifted to high dose (Fig. 1). Baseline characteristics, including Clinical Opioid Withdrawal Scale (COWS), were important predictors of retention. When controlled for the baseline characteristics, bup6 participants were three times less likely to drop out the first 7 days than bup1 participants (adjusted hazard ratio (aHR) = .28, p = .03). Opioid use and AEs were similar across trajectories. Participants on ≥16 mg BUP compared to those on

Background and Aims No effective pharmacotherapy for methamphetamine (MA) use disorder has yet been found. This study evaluated sustained-release methylphenidate (MPH-SR) compared with placebo (PLA) for treatment of MA use disorder in people also undergoing behavioral support and motivational incentives. Design This was a randomized, double-blind, placebo-controlled design with MPH-SR or PLA provided for 10 weeks (active phase) followed by 4 weeks of single-blind PLA. Twice-weekly clinic visits, weekly group counseling (CBT) and motivational incentives (MI) for MA-negative urine drug screens (UDS) were included. Setting Treatment sites were in Los Angeles, California (LA) and Honolulu, Hawaii (HH), USA. Participants A total of 110 MA-dependent (via DSM-IV) participants (LA = 90; HH = 20). Measurements The primary outcome measure is self-reported days of MA use during the last 30 days of the active phase. Included in the current analyses are drug use (UDS and self-report), retention, craving, compliance (dosing, CBT, MI), adverse events and treatment satisfaction. Findings No difference was found between treatment groups in self-reported days of MA use during the last 30 days of the active phase (P = 0.22). In planned secondary outcomes analyses, however, the MPH group had fewer self-reported MA use days from baseline through the active phase compared with the PLA group (P = 0.05). The MPH group also had lower craving scores and fewer marijuana-positive UDS than the PLA group in the last 30 days of the active phase. The two groups had similar retention, other drug use, adverse events and treatment satisfaction. Conclusions Methylphenidate may lead to a reduction in concurrent methamphetamine use when provided as treatment for patients undergoing behavioral support for moderate to severe methamphetamine use disorder, but this requires confirmation.

Background and objectives This analysis aims to: (1) compare induction experiences among participants who self-reported using one of the four most commonly reported POs, and (2) examine factors associated with difficult bup-nx induction. Our hypothesis, based on previous research and current guidelines, is that those on longer-acting opioids will have experienced more difficult inductions. Methods The Prescription Opioid Addiction Treatment Study (POATS) was a multi-site, randomized clinical trial, using a two-phase adaptive treatment research design. This analysis examines bup-nx induction of participants who self-reported primary PO use of methadone, ER-oxycodone, IR-oxycodone, and hydrocodone (n = 569). Analyses examined characteristics associated with difficult induction, defined as increased withdrawal symptoms measured by the Clinical Opiate Withdrawal Scale (COWS) after the first bup-nx dose with higher scores denoting greater withdrawal symptoms/severity. Results Contrary to our hypothesis, difficult induction experiences did not differ by primary PO type. Those who experienced a post-induction increase in COWS score had lower pre-dose COWS scores compared to those who did not experience a post-induction increase in COWS score (10.09 vs. 12.77, t(624) = −13.56, p

Although anxiety is one of the most prominent psychiatric complaints of methamphetamine (MA) users, little is known about the association between anxiety disorders and treatment outcomes in this population. Using data from 526 adults in the largest psychosocial clinical trial of MA users conducted to date, this study examined psychiatric, substance use, and functional outcomes of MA users with concomitant anxiety disorders 3 years after treatment. Anxiety disorders were associated with poorer alcohol and drug use outcomes, increased health service utilization, and higher levels of psychiatric symptomatology, including suicidality. Addressing anxiety symptoms and syndromes in MA users may be helpful as a means of optimizing treatment outcomes. (Am J Addict 2010;00:1–6)

Introduction and Aims. Although psychiatric symptoms are frequently observed in methamphetamine (MA) users, little is known about the prevalence of psychiatric disorders in MA-dependent individuals. This is the first study to examine the association of psychiatric disorders with substance use and psychosocial functioning in a large sample of MA users 3 years after treatment. We predicted that psychiatric diagnoses and severity would be associated with substance use and poorer overall functioning over the 3 year post-treatment course. Design and Methods. Participants (N = 526) received psychosocial treatment for MA dependence as part of the Methamphetamine Treatment Project and were reassessed for psychosocial functioning and substance use at a mean of 3 years after treatment initiation. DSM-IV psychiatric diagnoses were assessed at follow-up using the Mini-International Neuropsychiatric Interview. Psychosocial functioning was assessed using the Addiction Severity Index. Results. Overall, 48.1% of the sample met criteria for a current or past psychiatric disorder other than a substance use disorder. Consistent with prior reports from clinical samples of cocaine users, this rate was largely accounted for by mood disorders, anxiety disorders and antisocial personality. Those with an Axis I psychiatric disorder evidenced increased MA use and greater functional impairment over time relative to those without a psychiatric disorder. Discussion and Conclusions. This initial investigation of psychiatric diagnoses in MA users after treatment indicates elevated rates of Axis I and II disorders in this population and underscores the need for integrated psychiatric assessment and intervention in drug abuse treatment settings.[Glasner-Edwards S, Mooney LJ, Marinelli-Casey P, Hillhouse M, Ang A, Rawson RA, The Methamphetamine Treatment Project Corporate Authors. Psychopathology in methamphetamine-dependent adults 3 years after treatment. Drug Alcohol Rev 2009]