Clinical Trial Tobacco Marijuana

NCT ID: NCT02277665

Last Updated: 2019-01-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-18

Study Completion Date

2017-01-18

Brief Summary

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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.

Detailed Description

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Conditions

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Cannabis Use Disorder Tobacco Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CUD Treatment Only

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

Group Type ACTIVE_COMPARATOR

CUD Treatment

Intervention Type BEHAVIORAL

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

Group Type EXPERIMENTAL

CUD Treatment

Intervention Type BEHAVIORAL

Tobacco Treatment

Intervention Type BEHAVIORAL

Interventions

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CUD Treatment

Intervention Type BEHAVIORAL

Tobacco Treatment

Intervention Type BEHAVIORAL

Other Intervention Names

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Cognitive Behavioral Therapy and Contingency Management Behavioral Counseling plus NRT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Alan J. Budney

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alan J Budney, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Denise Walker, Ph.D

Role: PRINCIPAL_INVESTIGATOR

University of Washington School of Social Work

Locations

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Geisel School of Medicine at Dartmouth; State Building Site

Concord, New Hampshire, United States

Site Status

Geisel School of Medicine at Dartmouth; Rivermill Complex Site

Lebanon, New Hampshire, United States

Site Status

University of Washington School of Social Work

Seattle, Washington, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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5R01DA032243

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00028307 D14233

Identifier Type: -

Identifier Source: org_study_id

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