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Completed

NCT Number: NCT02277665

Clinical Trial Tobacco Marijuana

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.

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Key information

Conditions

Cannabis Use Disorder Behavior Chemically-Induced Disorders Mental Disorders Substance-Related Disorders Tobacco Use Tobacco Use Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Geisel School of Medicine at Dartmouth; State Building Site, Concord, New Hampshire, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CUD Treatment

Behavioral

Other names: Cognitive Behavioral Therapy and Contingency Management

Tobacco Treatment

Behavioral

Other names: Behavioral Counseling plus NRT

Primary outcomes

  1. Tobacco Quit Attempts

    Time frame: Week 12

    Percent of Participants who made at least one tobacco quit attempt

  2. Tobacco Abstinence

    Time frame: Weeks 9-12

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

  3. Cannabis Abstinence

    Time frame: Weeks 1-12

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

  4. Weeks of Continuous Cannabis Abstinence

    Time frame: Weeks 1-12

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

  5. Treatment Attendance

    Time frame: 12 weeks

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

  6. Initiation of Nicotine Replacement Therapy (NRT)

    Time frame: 24 weeks

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

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Acronym: RCTTM

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Oct 29, 2014
Registry last updated
Jan 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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