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Clinical Trial Tobacco Marijuana

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赞助商
Dartmouth-Hitchcock Medical Center
合作者
National Institute on Drug Abuse (NIDA)

关键词

抽象

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.

日期

最后验证: 11/30/2018
首次提交: 10/26/2014
提交的预估入学人数: 10/27/2014
首次发布: 10/28/2014
上次提交的更新: 12/16/2018
最近更新发布: 01/07/2019
首次提交结果的日期: 11/20/2018
首次提交质量检查结果的日期: 12/16/2018
首次发布结果的日期: 01/07/2019
实际学习开始日期: 12/17/2014
预计主要完成日期: 01/17/2017
预计完成日期: 01/17/2017

状况或疾病

Cannabis Use Disorder
Tobacco Use Disorder

干预/治疗

Behavioral: CUD Treatment

Behavioral: CUD and Tobacco Treatment

-

手臂组

干预/治疗
Active Comparator: CUD Treatment Only
12 Week Behavioral Treatment that included weekly computer-assisted counseling and contingency management for CUD
Experimental: CUD and Tobacco Treatment
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 and Tobacco Treatment

资格标准

有资格学习的年龄 18 Years 至 18 Years
有资格学习的性别All
接受健康志愿者
标准

Inclusion Criteria:

1. Individuals must be 18 years or older

2. 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

3. 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:

1. Current dependence on alcohol or any drug other than tobacco and cannabis

2. Use of non-tobacco nicotine

3. Current participation in structured treatment for substance abuse

4. Severe psychological distress (e.g., active suicidal plans, psychosis, debilitating panic disorder)

5. 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

6. Legal status that would interfere with participation

7. Living with someone currently enrolled in the project

8. Not being fluent in English

9. Not living within 45 miles of the research site

结果

主要结果指标

1. Tobacco Quit Attempts [Week 12]

Percent of Participants who made at least one tobacco quit attempt

2. Tobacco Abstinence [Weeks 9-12]

the percent of participants who achieve sustained tobacco abstinence, which reflects biologically-verified abstinence during weeks 5-12

3. Cannabis Abstinence [Weeks 1-12]

number of participants who achieved at least one week of documented cannabis abstinence during treatment

4. Weeks of Continuous Cannabis Abstinence [Weeks 1-12]

Weeks of Continuous Cannabis Abstinence among those achieving at least one week of abstinence

5. Treatment Attendance [12 weeks]

Attendance operationalized as the number of clinic visits (urine specimens provided)

6. Initiation of Nicotine Replacement Therapy (NRT) [24 weeks]

# of participants who initiated NRT during the 24 week study period

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