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临床试验/NCT02277665
NCT02277665已完成不适用

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

Dartmouth-Hitchcock Medical Center6 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2014年12月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
67
试验地点
6
主要终点
Initiation of Nicotine Replacement Therapy (NRT)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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

研究组 & 干预措施

CUD Treatment Only

Active Comparator

12 Week Behavioral Treatment that included weekly computer-assisted counseling and contingency management for CUD

干预措施: CUD Treatment (Behavioral)

CUD and Tobacco Treatment

Experimental

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

干预措施: CUD Treatment (Behavioral)

CUD and Tobacco Treatment

Experimental

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

干预措施: Tobacco Treatment (Behavioral)

结局指标

主要结局

Initiation of Nicotine Replacement Therapy (NRT)

时间窗: 24 weeks

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

Cannabis Abstinence

时间窗: Weeks 1-12

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

Tobacco Abstinence

时间窗: Weeks 9-12

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

Weeks of Continuous Cannabis Abstinence

时间窗: Weeks 1-12

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

Treatment Attendance

时间窗: 12 weeks

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

Tobacco Quit Attempts

时间窗: Week 12

Percent of Participants who made at least one tobacco quit attempt

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alan J. Budney

Professor

Dartmouth-Hitchcock Medical Center

研究点 (6)

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