Clinical Trial Tobacco Marijuana

Study Overview
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Brief Summary
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Approximately 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.

Official Title
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Randomized Trial Evaluating Treatment for Cannabis Use Disorders Among Those Who Use Tobacco

Conditions
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Cannabis Use Disorder, Tobacco Use Disorder

Intervention / Treatment
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* Behavioral: CUD Treatment
* Behavioral: Tobacco Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals must be 18 years or older Individuals must meet criteria for the current Diagnostic and Statistical Manual -IV diagnosis of cannabis abuse or dependence, report use of cannabis on at least 45 of the previous 90 days, and report regular use of tobacco cigarettes or report that their primary administration of cannabis is via blunts or spliffs Individual must indicate that they have at least some interest in quitting tobacco in the next 6 months (rating of 2 or more on a 5-point interest scale) Exclusion Criteria: Current dependence on alcohol or any drug other than tobacco and cannabis Use of non-tobacco nicotine Current participation in structured treatment for substance abuse Severe psychological distress (e.g., active suicidal plans, psychosis, debilitating panic disorder) Report of a condition that requires seeing a physician before using NRT (e.g., pregnancy or recent heart attack); note: if a participant's physician approves taking NRT, we will consider enrolling them Legal status that would interfere with participation Living with someone currently enrolled in the project Not being fluent in English Not living within 45 miles of the research site

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CUD Treatment Only<br>12 Week Behavioral Treatment that included weekly computer-assisted counseling and contingency management for CUD | Behavioral: CUD Treatment<br> <br> * Other names: Cognitive Behavioral Therapy and Contingency Management;|
| Experimental: CUD and Tobacco Treatment<br>12 Week Behavioral Treatment that included weekly computer-assisted counseling and contingency management for CUD, and behavioral counseling and nicotine replacement therapy (NRT) for tobacco | Behavioral: CUD Treatment<br> <br> * Other names: Cognitive Behavioral Therapy and Contingency Management;Behavioral: Tobacco Treatment<br> <br> * Other names: Behavioral Counseling plus NRT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tobacco Quit Attempts | Percent of Participants who made at least one tobacco quit attempt | Week 12 | 
| Tobacco Abstinence | the percent of participants who achieve sustained tobacco abstinence, which reflects biologically-verified abstinence during weeks 5-12 | Weeks 9-12 | 
| Cannabis Abstinence | number of participants who achieved at least one week of documented cannabis abstinence during treatment | Weeks 1-12 | 
| Weeks of Continuous Cannabis Abstinence | Weeks of Continuous Cannabis Abstinence among those achieving at least one week of abstinence | Weeks 1-12 | 
| Treatment Attendance | Attendance operationalized as the number of clinic visits (urine specimens provided) | 12 weeks | 
| Initiation of Nicotine Replacement Therapy (NRT) | # of participants who initiated NRT during the 24 week study period | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cannabis Use Disorder, Tobacco Use, Treatment