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Clinical Trial Tobacco Marijuana (RCTTM)

Primary Purpose

Cannabis Use Disorder, Tobacco Use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CUD Treatment
Tobacco Treatment
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cannabis Use Disorder focused on measuring Cannabis Use Disorder, Tobacco Use, Treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Geisel School of Medicine at Dartmouth; State Building Site
  • Geisel School of Medicine at Dartmouth; Rivermill Complex Site
  • University of Washington School of Social Work

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

CUD Treatment Only

CUD and Tobacco Treatment

Arm Description

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

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

Outcomes

Primary Outcome Measures

Tobacco Quit Attempts
Percent of Participants who made at least one tobacco quit attempt
Tobacco Abstinence
the percent of participants who achieve sustained tobacco abstinence, which reflects biologically-verified abstinence during weeks 5-12
Cannabis Abstinence
number of participants who achieved at least one week of documented cannabis abstinence during treatment
Weeks of Continuous Cannabis Abstinence
Weeks of Continuous Cannabis Abstinence among those achieving at least one week of abstinence
Treatment Attendance
Attendance operationalized as the number of clinic visits (urine specimens provided)
Initiation of Nicotine Replacement Therapy (NRT)
# of participants who initiated NRT during the 24 week study period

Secondary Outcome Measures

Full Information

First Posted
October 27, 2014
Last Updated
December 17, 2018
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT02277665
Brief Title
Clinical Trial Tobacco Marijuana
Acronym
RCTTM
Official Title
Randomized Trial Evaluating Treatment for Cannabis Use Disorders Among Those Who Use Tobacco
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
December 18, 2014 (Actual)
Primary Completion Date
January 18, 2017 (Actual)
Study Completion Date
January 18, 2017 (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
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CUD Treatment Only
Arm Type
Active Comparator
Arm Description
12 Week Behavioral Treatment that included weekly computer-assisted counseling and contingency management for CUD
Arm Title
CUD and Tobacco Treatment
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
CUD Treatment
Other Intervention Name(s)
Cognitive Behavioral Therapy and Contingency Management
Intervention Type
Behavioral
Intervention Name(s)
Tobacco Treatment
Other Intervention Name(s)
Behavioral Counseling plus NRT
Primary Outcome Measure Information:
Title
Tobacco Quit Attempts
Description
Percent of Participants who made at least one tobacco quit attempt
Time Frame
Week 12
Title
Tobacco Abstinence
Description
the percent of participants who achieve sustained tobacco abstinence, which reflects biologically-verified abstinence during weeks 5-12
Time Frame
Weeks 9-12
Title
Cannabis Abstinence
Description
number of participants who achieved at least one week of documented cannabis abstinence during treatment
Time Frame
Weeks 1-12
Title
Weeks of Continuous Cannabis Abstinence
Description
Weeks of Continuous Cannabis Abstinence among those achieving at least one week of abstinence
Time Frame
Weeks 1-12
Title
Treatment Attendance
Description
Attendance operationalized as the number of clinic visits (urine specimens provided)
Time Frame
12 weeks
Title
Initiation of Nicotine Replacement Therapy (NRT)
Description
# of participants who initiated NRT during the 24 week study period
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan J Budney, Ph.D
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Denise Walker, Ph.D
Organizational Affiliation
University of Washington School of Social Work
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
Facility Name
University of Washington School of Social Work
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

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Clinical Trial Tobacco Marijuana

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