Development and Efficacy Test of Computerized Treatment for Marijuana Dependence

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT00594659
First received: January 7, 2008
Last updated: December 3, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Marijuana Abuse and Dependence
Behavioral: Psychotherapy
Behavioral: Computerized Psychotherapy
Behavioral: Motivational enhancement therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Development and Efficacy Test of Computerized Treatment for Marijuana Dependence

Resource links provided by NLM:


Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • Consecutive Weeks of Marijuana Abstinence [ Time Frame: From the start of treatment through the end of the active treatment period, i.e., 12 weeks. ] [ Designated as safety issue: No ]
    Longest period of marijuana abstinence achieved during the 12-week treatment period documented by urine testing and self-report.

  • Point Prevalence Abstinence Post Treatment [ Time Frame: 9 months (from the end of treatment to 9 months post-treatment). ] [ Designated as safety issue: No ]
    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).


Enrollment: 75
Study Start Date: November 2008
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Therapist delivered cognitive behavioral treatment
Behavioral: Psychotherapy
Nine session treatment
Experimental: 2
Computerized Cognitive Behavioral treatment
Behavioral: Computerized Psychotherapy
Nine session computer delivered treatment
Active Comparator: 3
Motivational enhancement therapy
Behavioral: Motivational enhancement therapy
Two session treatment

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00594659

Locations
United States, New Hampshire
Geisel School of Medicine at Dartmouth
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
Principal Investigator: Alan J Budney, Ph.D. Geisel School of Medicine at Dartmouth
  More Information

No publications provided

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00594659     History of Changes
Other Study ID Numbers: 88268, 1R01DA023526-01, 1R01DA023526-02, 1R01DA023526-03
Study First Received: January 7, 2008
Results First Received: April 16, 2013
Last Updated: December 3, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Dartmouth-Hitchcock Medical Center:
Marijuana
Treatment
Behavioral
Computer
Internet

Additional relevant MeSH terms:
Marijuana Abuse
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 22, 2014