Clinical Trial Tobacco Marijuana

NCT02277665 | Completed Results DMC

• 2 other identifiers: STUDY00028307 D142335R01DA032243
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Cannabis Use Disorder; Tobacco Use Disorder

Keywords

Cannabis Use Disorder; Tobacco Use; Treatment

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

CUD Treatment Only

ACTIVE COMPARATOR

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

Behavioral: CUD Treatment

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

Behavioral: CUD Treatment; Behavioral: Tobacco Treatment

Interventions

CUD Treatment BEHAVIORAL

Also known as: Cognitive Behavioral Therapy and Contingency Management

CUD Treatment Only; CUD and Tobacco Treatment

Tobacco Treatment BEHAVIORAL

Also known as: Behavioral Counseling plus NRT

CUD and Tobacco Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (3)

Geisel School of Medicine at Dartmouth; State Building Site

Concord, New Hampshire, 03301, United States

Location

Geisel School of Medicine at Dartmouth; Rivermill Complex Site

Lebanon, New Hampshire, 03766, United States

Location

University of Washington School of Social Work

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Tobacco Use

Interventions

Cognitive Behavioral Therapy; Behavior Therapy; Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Drug Therapy; Therapeutics

Limitations and Caveats

Enrollment did not meet planned target numbers, limiting the power to detect differences between conditions.

Results Point of Contact

• Title: Dr. Alan J. Budney
• Organization: Dartmouth-Hitchcock

alan.j.budney@dartmouth.edu

603-646-7088

Study Officials

• Alan J Budney, Ph.D

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

• Denise Walker, Ph.D

  University of Washington School of Social Work

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 27, 2014
• First Posted: October 29, 2014
• Study Start: December 18, 2014
• Primary Completion: January 18, 2017
• Study Completion: January 18, 2017
• Last Updated: January 8, 2019
• Results First Posted: January 8, 2019

Record last verified: 2018-12

Locations

US (3)