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Targeting Tobacco Cessation During Treatment for Cannabis Use Disorders

Primary Purpose

Cannabis Dependence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MET/CBT/CM plus NRT
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cannabis Dependence focused on measuring Tobacco Use

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Geisel School of Medicine at Dartmouth; State Building Site
  • Geisel School of Medicine at Dartmouth; Rivermill Complex Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MET/CBT/CM plus NRT

Arm Description

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.

Outcomes

Primary Outcome Measures

Tobacco Quit Attempts
Sum of 24 hour quit attempts

Secondary Outcome Measures

Cannabis Abstinence: continuous weeks of abstinence achieved during the 12 week treatment period
Urinalysis tests and self-report data will be collected twice per week during participation in the study

Full Information

First Posted
April 15, 2013
Last Updated
January 11, 2019
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01834794
Brief Title
Targeting Tobacco Cessation During Treatment for Cannabis Use Disorders
Official Title
Targeting Tobacco Cessation During Treatment for Cannabis Use Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Dependence
Keywords
Tobacco Use

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MET/CBT/CM plus NRT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
MET/CBT/CM plus NRT
Intervention Description
Behavioral Treatment for Cannabis plus Behavioral Treatment for Tobacco: both primarily delivered by computer. Additional NRT.
Primary Outcome Measure Information:
Title
Tobacco Quit Attempts
Description
Sum of 24 hour quit attempts
Time Frame
Will be assessed for the duration of study, an average of 16 weeks
Secondary Outcome Measure Information:
Title
Cannabis Abstinence: continuous weeks of abstinence achieved during the 12 week treatment period
Description
Urinalysis tests and self-report data will be collected twice per week during participation in the study
Time Frame
Will be assessed twice per week for the duration of the study treatment period, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan J Budney
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geisel School of Medicine at Dartmouth; State Building Site
City
Concord
State/Province
New Hampshire
ZIP/Postal Code
03301
Country
United States
Facility Name
Geisel School of Medicine at Dartmouth; Rivermill Complex Site
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03766
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24813547
Citation
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.
Results Reference
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Targeting Tobacco Cessation During Treatment for Cannabis Use Disorders

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