Targeting Tobacco Cessation During Treatment for Cannabis Use Disorders

NCT ID: NCT01834794

Last Updated: 2019-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2015-01-31

Brief Summary

This project aims to develop and test an intervention for the simultaneous treatment of cannabis use disorders and tobacco smoking. This is important because over 50% of adults seeking treatment to help stop cannabis use also smoke tobacco regularly, which decreases their chance for a successful treatment outcome and increases adverse acute and long-term psychosocial and health consequences. The proposed treatment will integrate existing computer-based behavioral interventions for cannabis and tobacco and use nicotine replacement medications to improve outcomes in this difficult to treat clinical population.

Detailed Description

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. A two-phase, Stage 1 therapy development project will accomplish the following: First, a treatment protocol and manual will be developed that integrates a tailored intervention for tobacco smoking with an intervention for CUD (Aim 1). Utilization of web-based counseling programs will standardize delivery of the intervention and foster eventual dissemination. A pilot study will provide an initial test of acceptability and feasibility. Second, a Stage 1, proof-of-concept study will compare this intervention to one that targets CUD only (Aim 2). The 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 (Aim 3). 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 Dependence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MET/CBT/CM plus NRT

Motivational Enhancement Therapy, Cognitive Behavior Therapy, Contingency Management plus Nicotine Replacement Therapy (MET/CBT/CM) + NRT

Behavioral Treatment for Cannabis plus Behavioral Treatment for Tobacco: both primarily delivered by computer. Additional NRT.

Group Type: EXPERIMENTAL

MET/CBT/CM plus NRT

Intervention Type: BEHAVIORAL

Behavioral Treatment for Cannabis plus Behavioral Treatment for Tobacco: both primarily delivered by computer. Additional NRT.

Interventions

MET/CBT/CM plus NRT

Behavioral Treatment for Cannabis plus Behavioral Treatment for Tobacco: both primarily delivered by computer. Additional NRT.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 18-65 years old
• current DSM-IV diagnosis of cannabis abuse or dependence
• report use of cannabis on at least 45 of previous 90 days
• report regular use of tobacco cigarettes or report that their primary administration of cannabis is via blunts or spliffs
• some indication of 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
• active or recent suicidal ideation
• use of non-tobacco nicotine
• current participation in treatment for substance abuse
• severe psychological distress (e.g., active suicidal plans, psychosis, debilitating panic disorder).
• a condition that requires seeing a physician before using NRT (e.g., pregnancy or recent heart attack
• legal status that would interfere with participation
• living with someone enrolled in the project
• not living within 30 miles of the research site (unless an exception is authorized by the PI)
• not being fluent in english

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Alan J. Budney

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alan J Budney

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Locations

Geisel School of Medicine at Dartmouth; State Building Site

Concord, New Hampshire, United States

Geisel School of Medicine at Dartmouth; Rivermill Complex Site

Lebanon, New Hampshire, United States

Countries

United States

References

Lee DC, Budney AJ, Brunette MF, Hughes JR, Etter JF, Stanger C. Treatment models for targeting tobacco use during treatment for cannabis use disorder: case series. Addict Behav. 2014 Aug;39(8):1224-30. doi: 10.1016/j.addbeh.2014.04.010. Epub 2014 Apr 13.

Reference Type: RESULT

PMID: 24813547 (View on PubMed)

Other Identifiers

1R01DA032243-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

32243 D14201

Identifier Type: -

Identifier Source: org_study_id