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Development and Efficacy Test of Computerized Treatment for Marijuana Dependence

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ClinicalTrials.gov Identifier: NCT00594659
Recruitment Status : Completed
First Posted : January 16, 2008
Results First Posted : December 4, 2013
Last Update Posted : December 4, 2013
Sponsor:
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center

Tracking Information
First Submitted Date  ICMJE January 7, 2008
First Posted Date  ICMJE January 16, 2008
Results First Submitted Date  ICMJE April 16, 2013
Results First Posted Date  ICMJE December 4, 2013
Last Update Posted Date December 4, 2013
Study Start Date  ICMJE November 2008
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2013)
  • Consecutive Weeks of Marijuana Abstinence [ Time Frame: From the start of treatment through the end of the active treatment period, i.e., 12 weeks. ]
    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). ]
    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).
Original Primary Outcome Measures  ICMJE
 (submitted: January 15, 2008)
Marijuana Use [ Time Frame: One Year ]
Change History Complete list of historical versions of study NCT00594659 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2008)
Marijuana Dependence [ Time Frame: One Year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Development and Efficacy Test of Computerized Treatment for Marijuana Dependence
Official Title  ICMJE Development and Efficacy Test of Computerized Treatment for Marijuana Dependence
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Marijuana Abuse and Dependence
Intervention  ICMJE
  • Behavioral: Psychotherapy
    Nine session treatment
  • Behavioral: Computerized Psychotherapy
    Nine session computer delivered treatment
  • Behavioral: Motivational enhancement therapy
    Two session treatment
Study Arms  ICMJE
  • Active Comparator: 1
    Therapist delivered cognitive behavioral treatment
    Intervention: Behavioral: Psychotherapy
  • Experimental: 2
    Computerized Cognitive Behavioral treatment
    Intervention: Behavioral: Computerized Psychotherapy
  • Active Comparator: 3
    Motivational enhancement therapy
    Intervention: Behavioral: Motivational enhancement therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 3, 2013)
75
Original Estimated Enrollment  ICMJE
 (submitted: January 15, 2008)
145
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00594659
Other Study ID Numbers  ICMJE 88268
1R01DA023526-01 ( U.S. NIH Grant/Contract )
1R01DA023526-02 ( U.S. NIH Grant/Contract )
1R01DA023526-03 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dartmouth-Hitchcock Medical Center
Study Sponsor  ICMJE Dartmouth-Hitchcock Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alan J Budney, Ph.D. Dartmouth College
PRS Account Dartmouth-Hitchcock Medical Center
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP