Clinical Trial Tobacco Marijuana
Cannabis Use DisorderTobacco Use DisorderApproximately 50% of persons seeking treatment for cannabis-use disorders (CUDs) regularly smoke tobacco. Combining tobacco with cannabis has become a common method of smoking cannabis. Similarities of use, and using together, can make quitting difficult. Stopping tobacco simultaneously with cannabis may be beneficial. Little scientific information currently addresses how to best target tobacco smoking during treatment for CUDs. Our long-term goal is to develop an effective protocol for intervening in tobacco smoking without changing cannabis outcomes. This protocol reflects the planned Stage 1, proof-of-concept study that will compare a combined cannabis and tobacco intervention to one that targets CUD only. Hypotheses assert that the intervention (1) will be accepted by the majority of eligible participants (2) will result in more tobacco quit attempts and rates than the CUD-only treatment; and (3) will not adversely affect cannabis outcomes. Last, the project will evaluate the potential of specific moderators of outcomes to predict outcomes and inform subsequent treatment development efforts. If the hypotheses were confirmed, dissemination of this protocol would reduce adverse psychosocial and health consequences of tobacco or cannabis dependence. Findings will inform future development of prevention and intervention strategies.
Quetiapine Pharmacotherapy for Cannabis Dependence
Cannabis DependenceDespite a benign public perception, marijuana use disorders represent a significant public health problem. The development of safe and effective pharmacotherapies for marijuana dependence is an important unmet public health need. Quetiapine, an effective atypical antipsychotic that acts by blocking serotonin type 2A, dopamine type 2, histamine type 1, and adrenergic receptors, is a promising treatment for substance use disorders. In animal models, quetiapine blocks the enhancement of reward by cocaine, which is likely due to its actions on both dopamine and non-dopamine neurotransmission. Clinical studies of quetiapine have shown benefit for the treatment of alcohol and cocaine use disorders. Conceptually, the clinically prominent effects of quetiapine, namely sedation, anxiolysis, mood stabilization and appetite stimulation, are a good match for the symptoms of marijuana withdrawal. Most importantly, an open-label dose-finding study of quetiapine for the treatment of marijuana dependence conducted by our research group determined that quetiapine was well-tolerated and associated with reductions in marijuana use indicating that it is a promising agent deserving of further study in marijuana-dependent outpatients. The proposed research project is a randomized double-blind placebo-controlled clinical trial to evaluate the efficacy of quetiapine for the treatment of marijuana dependence over a 12-week period. All participants will receive Medical Management, a medication adherence focused psychosocial intervention that facilitates compliance with study medication and other study procedures, promotes abstinence from marijuana and other substances, and encourages mutual-support group attendance. All participants will receive voucher incentives for compliance with study visit attendance, returning study medication bottles, and completing other study procedures, with the objective of achieving a highly compliant sample. The goal of this phase II clinical trial is to build on our promising open-label pilot study results and examine the efficacy of quetiapine on participants' marijuana consumption under placebo-controlled double-blind conditions using an abstinence-initiation model, where participants will be using marijuana regularly at study entry, reduce their use, and then achieve abstinence. The specific aims of the projects are to determine whether quetiapine is superior to placebo in 1) reducing marijuana use and 2) achieving abstinence.
Sativex and Behavioral-relapse Prevention Strategy in Cannabis Dependence
Cannabis DependenceThe purpose of this study is assess Sativex as a treatment for Cannabis dependence. Initially a pilot study will be conducted in five subjects seeking treatment for cannabis dependence to ensure that our planned self-titration regimen is appropriate using Sativex. This phase will be open label, with no placebo control. Then, there will be a twelve-week, double-blind, placebo-controlled study in male and female subjects seeking treatment for cannabis dependence (n=40). All participants will receive a combination of pharmacotherapy (Sativex Spray or Placebo Spray) associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy (MET/CBT). The subjects will have to come daily to the centre to assess usage of medication. Following the medication phase, participants will have a follow-up weekly for another four weeks and then monthly until the 6 month follow up visit after the target quit date. The investigators are planning to enroll 45 subjects over the two-year period.
Marijuana Treatment Project 4
Marijuana DependenceMarijuana is the most commonly used illicit drug in the US, but treatment for marijuana dependence is not fully effective. In the current proposal we are exploring the idea that more tailored teaching of coping skills may result in improved outcomes for marijuana-dependence than those seen thus far. Participants will be 275 men and women meeting criteria for marijuana dependence and randomly assigned to 9 sessions of treatment in one of 4 treatment conditions: Standardized MET plus CB (SMET-CB); SMET+ CM (SMET-CB-CM); IATP; or IATP + CM (IATP-CM). Patients in all treatments will engage in ES via cell-phone for two weeks prior to treatment, for a weekly period during treatment, for another week after treatment has ended, and for two weekly periods at months 8 and 14. In the IATP conditions, the information gathered from the pretreatment and during-treatment ES periods will provide data for a functional analysis of patients' drug use and urges to use. It is hypothesized that IATP conditions will yield significantly better coping skills acquisition than SMET-CB conditions, both at posttreatment and at extended follow-ups, and that change in coping skills will predict better outcomes for the IATP conditions
Effect of Cannabis and Endocannabinoids on HIV Neuropathic Pain
CannabisHIV Neuropathy1 moreAcute cannabis administration is reported to alleviate HIV neuropathic pain (HIV-NP), but there is limited knowledge about the effects of cannabis constituents (delta-9 tetrahydrocannabinol/THC and cannabidiol/CBD), the consequences of long-term cannabis use, and the impact of cannabis on endocannabinoid (EC) function in people living with HIV- NP. Our objective is to address these three fundamental gaps in our knowledge by: 1) examining the acute effects of various CBD/THC products on HIV-NP, 2) utilizing a mHealth text messaging protocol, Individual Monitoring of Pain and Cannabis Taken (IMPACT) to monitor daily real-world cannabis use and changes in pain; and 3) studying the relationship between cannabinoids, EC biomarkers, and chronic neuropathic pain
Effect of Clonazepam on Cannabis Withdrawal and Relapse in Treatment-seeking Patients
Cannabis Use DisorderThe proposed protocol is a double-blind, placebo-controlled inpatient and outpatient study,looking at the clinical treatment of cannabis use disorder. The treatment study is a total of 12 weeks. There will be two options offered to participants for week 1 of the treatment study. 1) Patient will go inpatient for 5 nights and after discharge from the inpatient phase will complete the 11-weeks of outpatient treatment or 2) patients who cannot complete the inpatient phase due to work or other obligations will complete the treatment 12-week study outpatient. 80 patients seeking treatment for cannabis use disorder will be enrolled into either the inpatient/outpatient or only outpatient study. This combined design will provide a comprehensive understanding of clonazepam's effects on individuals with cannabis use disorder across a range of outcome measures while also testing the medication's ability to prevent relapse in cannabis-abstinent patients.
Pilot Test of Parent-Focused Cannabis-Related Actions and Practices Intervention for Adolescent...
Cannabis Use DisorderMild2 moreThe randomized clinical trial involves the pilot-testing of a theory-guided, empirically based, and low-cost intervention designed for legal medical marijuana-using parents to enhance parenting behaviors that limit youth exposure to marijuana, reduce or halt youth marijuana use, and increase youth awareness of the harmful consequences of marijuana during the youth years. Parents will be randomized to an intervention condition or to a wait list control condition. Pre- and post-intervention assessments will evaluate parent and youth marijuana and other substance use, perceptions and attitudes about marijuana, parenting and family functioning, and youth behavioral health.
Brain Exercise and Addiction Trial
Cannabis Use DisorderModerate2 moreHeavy cannabis use is associated with substantive learning and memory impairments and elevated risk of psychopathology. It has been repeatedly demonstrated that the hippocampus, centrally implicated in these processes, is particularly vulnerable to the deleterious effects of prolonged exposure to cannabis. This deterioration of hippocampal structure, function, and biochemistry can be reversed, but this requires two or more years of abstinence from cannabis. However, most heavy cannabis users find it extremely difficult to maintain abstinence over extended periods and current treatments for cannabis use disorders are inadequate. There is a pressing clinical need for an intervention that rapidly accelerates hippocampal recovery, ameliorates the associated cognitive impairments and mental health symptoms, and leads to improved treatment outcomes. One promising candidate is physical exercise. In addition to the well-known physical health benefits, regular exercise also has a potent positive effect on brain health. The current study will investitive the capacity of two different neuroscientifically-informed 12-week exercise programs can restore brain health for heavy long term cannabis users.
Cannabis Use and Relapse After One Week of Contingency Management Therapy
Cannabis DependenceThe purpose of this study is to examine the effects of a seven-day combined contingency management (CM) with two sessions of brief Motivation Interviewing (MI) followed by standardized individual drug counseling on cannabis use and relapse in the following 90-day period in individuals with moderate to severe Cannabis Use Disorder (DSM-5).
Open-Label Pilot Study of Guanfacine-Extended Release for the Treatment of Cannabis Dependence
Cannabis DependenceThe purpose of this study is to determine whether guanfacine represents a tolerable, potentially effective pharmacotherapy option for cannabis dependence. Interested in seeing whether guanfacine treatment reduces marijuana consumption, withdrawal symptoms, and craving as compared to baseline.