Active clinical trials for "Substance-Related Disorders"

In this study, the investigators seek to evaluate the effects of cannabidiol (CBD) on cocaine craving and relapse. Cocaine addiction is characterized by compulsive substance use and repetitive urges to consume the drug even after a sustained period of abstinence. While substance use remains the most obvious direct outcome of addiction, there is a growing interest in other core symptoms of this disorder. Craving has become a subject of great interest as it is a reliable intermediate phenotype of cocaine relapse and a distressing symptom of addiction associated with suffering. Indeed, even after a period of abstinence, cocaine-dependent individuals remain vulnerable to stress and other craving-inducing stimuli, which, in turn, lead to intense physiological responses and various negative feelings such as anger and sadness. Real-time daily monitoring of craving and drug use has shown that craving predicts cocaine relapse among cocaine-dependent individuals. In sum, working toward improving the treatment of craving could not only help prevent relapse, but also reduce patient distress on emotional, cognitive, and physiological levels. In the past decades, significant scientific efforts have been deployed toward the development of innovative strategies to beat cocaine addiction, but with partial success thus far. Psychosocial approaches have been widely used to help cocaine-dependent patients achieve better outcomes after drug cessation, but literature indicates that these strategies alone are at times insufficient to induce significant behavioural changes or a reduction in rates of drug consumption. Unlike other types of addiction, such as opioid and alcohol, no pharmacological treatment has yet been found to be truly effective in relieving cocaine-cessation symptoms like craving and anxiety or to prevent relapse. CBD is a natural cannabinoid with a favourable tolerability profile and discrete neurobiological actions that are linked to neural circuits closely involved in addiction disorders. Addiction to cocaine is characterized by alternating phases of intoxication and short abstinence, followed by recurrent drug-craving episodes which result in distress and relapse. Our hypothesis is that CBD a cannabinoid known for its broad spectrum properties is an interesting pharmacological contender to decrease cocaine craving and treat cocaine addiction. Previous studies conducted in animals and humans confirm that CBD is a very safe and tolerable medication.

A multi-center, open-label, long-term safety study in which approximately 600 subjects diagnosed with opioid use disorder will be enrolled. Following a screening period, all subjects will receive run in SUBOXONE sublingual film followed by an initial injection of open-label high dose (300 mg) RBP-6000. The RBP-6000 monthly injection dose can be adjusted to low dose (100 mg), and back to high dose, based on the medical judgment of the Investigator. Subjects will participate in the study for either 6 or 12 months.

The purpose of this study is to determine whether Moral Reconation Therapy (MRT) is effective for reducing risk of criminal recidivism and improving other health-related outcomes (substance use, mental health, housing, and employment problems) among justice-involved Veterans entering residential mental health treatment programs in the Department of Veterans Affairs (VA).

In response to the Rehabilitation Research and Development (RR&D) Deployment Health Research, this study addresses the delivery of an evidenced-based vocational rehabilitation, specifically Individual Placement and Support (IPS), for Veterans who are facing unemployment and mental illness as they try to recovery and re-establish civilian life. This study provides the requisite evidence needed to guide the Veterans Health Administration (VHA) as to whether to expand the target population for IPS to Veterans with any mental disorder, delivered directly within the primary care setting (i.e. Patient Aligned Care Team; PACT). Such modifications in VHA practice could substantially improve Veteran vocational rehabilitation access and outcomes, moving a significantly greater number of disabled Veterans back to full and productive lives in the community.

Primary Objective: This study will evaluate the effectiveness of an HCV Care Facilitation intervention in moving HIV/HCV co-infected substance users forward along the HCV care continuum (compared with a Control group). Primary Hypothesis: The number of steps achieved along the HCV care continuum will differ between the two study groups over the 14-month follow-up period. Secondary Objectives: Component 1 (Long-term CTN 0049 follow-up): Using the CTN 0064 baseline data (self-report, medical record abstraction and biological data), the following CTN 0049 primary and secondary outcomes in participants who consented to the CTN 0064 protocol will be re-analyzed to evaluate latent and/or enduring effects of the CTN 0049 interventions: HIV virological suppression HIV primary care visit attendance All-cause mortality

Open-label multi-center, 48 week safety study, consistent with standard practice for long-term safety studies. This one year safety study will utilize CAM2038 q1w (once weekly) and q4w (once monthly) and will have 3 phases: Screening, Treatment, and Follow-up.

The Sponsor is doing a research study to assess the effects of a smartphone program designed to help users smoke less and eventually quit. When participants join, their involvement in the core study will last 8 weeks. After 8 weeks, they will have the option to continue using the program to guide their quit journey or participate in follow-up research.

This project will examine effects of bupropion extended release (XL) at a dose of 300mg/day for cocaine abstinence among persons receiving methadone for the treatment of opioid use disorder. Participants also earned financial incentives for providing urine samples that tested negative for cocaine. Bupropion was examined for this purpose because of its previously demonstrated efficacy and safety as well as its pharmacological actions at dopamine systems. Participants were randomly assigned to bupropion XL vs. placebo and received different incentive schedules depending on whether they demonstrated abstinence from cocaine early in the study. Outcomes were tracked over a 6-month time frame and the overarching hypothesis was that bupropion (as compared to placebo) would increase the number of urine samples testing negative for cocaine, independent of whether participants demonstrated abstinence from cocaine early in the study.

This Stage II randomized trial tests Culturally Informed & Flexible Family Based Treatment for Adolescents (CIFFTA) developed as part of a Stage I treatment development effort and yielding promising preliminary findings. Drug use rates are highest among Hispanic middle school youth and to date no treatments have met criteria for "Well Established" in the treatment of substance abuse in Hispanic adolescents. Further treatment for Hispanic youth and families is complicated by the fact that these families often differ from mainstream populations in culture-related values, beliefs and behaviors that can directly impact engagement, retention, and efficacy/effectiveness of drug treatment. Our efforts to develop a more powerful treatment capable of addressing these issues began with a Stage 1 study that led to the development of a multi-component treatment that includes a flexible manual that allows treatment tailoring to the unique characteristics of individual families. CIFFTA integrates innovative culturally-based, individually-based, and family-based components to: 1) reduce maladaptive family processes (e.g., poor parenting practices, family conflict) and increase family protective factors (e.g., strong parent-child attachment), 2) teach adolescents skills to effectively manage interpersonal conflicts and stressors and to increase motivation to change, 3) deliver psycho-educational and culturally congruent material (e.g., modules on immigration stressors) to youth and parents both separately and together, and 4) deliver the intervention using a flexible treatment manual that allows the clinician to tailor the treatment (e.g., by selecting the most relevant psycho-educational modules and themes) to the unique characteristics and needs of the Hispanic family. This Stage II randomized trial randomizes 220 Hispanic adolescents ages 14-17 who meet DSM-IV criteria for Substance Abuse to a 4-month treatment of either CIFFTA or Traditional Family Therapy. The study tests CIFFTA's efficacy in impacting drug use, risky sexual behavior, and other severe behavior problems, and hypothesized mechanisms of change, in a larger and more rigorous Stage II trial. Assessments occur at baseline, 4 months post baseline (end of treatment), 10 months post baseline and 16 months post baseline. Should this line of research continue to be successful, it has the potential to contribute to the field a highly innovative and efficacious treatment for Hispanic drug abusing adolescents, a better understanding of mechanisms of treatment efficacy, and also a framework for future flexible and tailored treatments that can be used to better address the unique needs of other special populations.

Building on the recent advances in telephone supported care, clinical monitoring, and outreach work, the specific aims of the study are to: Develop RecoveryTrack™- ExtendedCare (RT-E), a modified/new version of RecoveryTrack™. The investigators will adapt and finalize the original Web-based RT system, manual, and training to accommodate use by counselors for clients who are no longer attending Outpatient (OP) treatment. Conduct a pilot study to determine the preliminary efficacy of RT-E compared to treatment as usual (TAU) for clients entering Intensive Outpatient (IOP) substance abuse treatment (SAT). In this randomized clinical trial, it is hypothesized that RT-E will positively impact treatment attendance and substance use outcomes. In exploratory analyses, the investigators will also evaluate the comparative impact of RT-E versus TAU on HIV related client behaviors. Evaluate feasibility and counselor and client acceptability of RT-E. Conduct preliminary cost and cost effectiveness analyses comparing RT-E to TAU. Hypothesis 1: RT-E clients will attend more days of OP treatment than TAU clients. The investigators will compare the two groups on monthly treatment attendance for months 1 through 9. We expect a main effect of group with RT-E clients displaying more attendance than TAU clients. Hypothesis 2: RT-E clients will have higher rates of abstinence than TAU clients. The investigators will compare abstinence rates at months 3, 6, and 9. Abstinence is a binary variable based on both biological test results and self-reported substance use from the Addiction Severity Index, Version 6 (ASI6). We expect a main effect of group with RT-E clients displaying higher rates of abstinence than TAU clients. Secondary Analyses: HIV Risk Scores: The investigators will compare the two groups' Risk Assessment Battery (RAB) HIV risk scores (i.e., total, sex, drug) at month 9. Use of HIV specialist services: Client attendance charts will be reviewed to compare the two groups on the number of times clients met with a program HIV Specialist at month 9. Multidimensional Outcomes: The investigators will compare RT-E and TAU clients on multidimensional outcomes using ASI6 summary scores at months 3, 6, and 9.