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Development and Efficacy Test of Computerized Treatment for Marijuana Dependence

Primary Purpose

Marijuana Abuse and Dependence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Psychotherapy
Computerized Psychotherapy
Motivational enhancement therapy
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Marijuana Abuse and Dependence focused on measuring Marijuana, Treatment, Behavioral, Computer, Internet

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 18 years of age or older
  • Meet criteria for current DSM-IV diagnosis of marijuana abuse or dependence
  • Report use of marijuana on at least 40 of the past 90 days
  • Severe psychological distress

Exclusion Criteria:

  • Current dependence on alcohol or any other drug (except nicotine)
  • Participation in treatment for alcohol/drug problem
  • A legal status which will interfere with participation
  • Plans to move out of the area in the next 12 months
  • Living with someone who is already enrolled in the project
  • Not living within approximately 30 miles of the research site
  • Not being fluent in English

Sites / Locations

  • Geisel School of Medicine at Dartmouth

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Active Comparator

Arm Label

1

2

3

Arm Description

Therapist delivered cognitive behavioral treatment

Computerized Cognitive Behavioral treatment

Motivational enhancement therapy

Outcomes

Primary Outcome Measures

Consecutive Weeks of Marijuana Abstinence
Longest period of marijuana abstinence achieved during the 12-week treatment period documented by urine testing and self-report.
Point Prevalence Abstinence Post Treatment
Percent of participants that were marijuana abstinent based on urine toxicology testing at each follow up assessment across 9 month follow up period ( at the end of treatment, at 3-months, 6-months, and 9 months post the end of treatment).

Secondary Outcome Measures

Full Information

First Posted
January 7, 2008
Last Updated
December 3, 2013
Sponsor
Dartmouth-Hitchcock Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00594659
Brief Title
Development and Efficacy Test of Computerized Treatment for Marijuana Dependence
Official Title
Development and Efficacy Test of Computerized Treatment for Marijuana Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dartmouth-Hitchcock Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
More US residents are dependent on marijuana than on any other illicit drug, and the number enrolled in treatment for marijuana continues to increase such that it is now comparable to that for cocaine and heroin. This application seeks to advance the overarching goal to develop and disseminate cost-effective treatments for marijuana dependence that can address this growing problem. The researchers' previous research suggests that an intervention comprising motivational enhancement, cognitive-behavioral, and contingency-management components (MET/CBT/CM) produces greater rates of successful and durable outcomes than has been demonstrated previously. However, three issues relevant to its efficacy and eventual dissemination must be confronted. First, the outcomes achieved can only be characterized as modest; many individuals do not respond to the treatment and relapse rates remain problematic. Second, access is limited by the availability of trained providers. Third, the cost of delivering the treatment is higher than more traditional outpatient interventions. To address these issues, Specific Aim 1 is to develop and test a computer-assisted version of MET/CBT/CM. Computerized treatments have the potential to increase overall effectiveness of treatment services by increasing availability of and access to potent treatments, and by applying innovative technology to enhance outcomes. During Year 1, the intervention will be developed and pilot tested. An interactive program that showed promise in a previous trial for opioid dependence will be modified and enhanced to deliver individualized MET/CBT/CM using effective computer learning technologies. These technologies and access to the MET/CBT/CM program made available via the Internet between treatment sessions and after treatment ends have the potential to promote better learning and more use of coping skills, which in turn can improve outcomes. During Years 2-4 a randomized trial will provide an initial efficacy test of cMET/CBT/CM by comparing it with a brief treatment (MET) and with therapist-delivered MET/CBT/CM. Specific Aim 2 is to learn more about how behavioral treatments like MET/CBT/CM work by focusing on two putative mechanisms of action examined in prior trials: self-efficacy/coping skills and impulsivity/delay discounting. The experimental design will provide a unique opportunity to explore such mechanisms in a novel context- where the therapist is vs. is not a prominent part of the treatment. The proposed project will address the objectives of NIDA's Behavioral and Integrative Treatment Development Program by providing research on technology-assisted treatment that attempts to make treatment delivery less complex, easier to access, and less costly - while retaining or improving its effectiveness. Findings will inform future studies designed to refine the technology and how it is applied; conduct more definitive effectiveness testing; test generality to other populations including adolescents; and to further advance translation to community settings.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Marijuana Abuse and Dependence
Keywords
Marijuana, Treatment, Behavioral, Computer, Internet

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Therapist delivered cognitive behavioral treatment
Arm Title
2
Arm Type
Experimental
Arm Description
Computerized Cognitive Behavioral treatment
Arm Title
3
Arm Type
Active Comparator
Arm Description
Motivational enhancement therapy
Intervention Type
Behavioral
Intervention Name(s)
Psychotherapy
Intervention Description
Nine session treatment
Intervention Type
Behavioral
Intervention Name(s)
Computerized Psychotherapy
Intervention Description
Nine session computer delivered treatment
Intervention Type
Behavioral
Intervention Name(s)
Motivational enhancement therapy
Intervention Description
Two session treatment
Primary Outcome Measure Information:
Title
Consecutive Weeks of Marijuana Abstinence
Description
Longest period of marijuana abstinence achieved during the 12-week treatment period documented by urine testing and self-report.
Time Frame
From the start of treatment through the end of the active treatment period, i.e., 12 weeks.
Title
Point Prevalence Abstinence Post Treatment
Description
Percent of participants that were marijuana abstinent based on urine toxicology testing at each follow up assessment across 9 month follow up period ( at the end of treatment, at 3-months, 6-months, and 9 months post the end of treatment).
Time Frame
9 months (from the end of treatment to 9 months post-treatment).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18 years of age or older Meet criteria for current DSM-IV diagnosis of marijuana abuse or dependence Report use of marijuana on at least 40 of the past 90 days Severe psychological distress Exclusion Criteria: Current dependence on alcohol or any other drug (except nicotine) Participation in treatment for alcohol/drug problem A legal status which will interfere with participation Plans to move out of the area in the next 12 months Living with someone who is already enrolled in the project Not living within approximately 30 miles of the research site Not being fluent in English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan J Budney, Ph.D.
Organizational Affiliation
Dartmouth College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geisel School of Medicine at Dartmouth
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.uams.edu/psych/car/
Description
Related Info

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Development and Efficacy Test of Computerized Treatment for Marijuana Dependence

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