Development and Efficacy Test of Computerized Treatment for Marijuana Dependence

NCT00594659 | Completed Results

• 4 other identifiers: 882681R01DA023526-011R01DA023526-021R01DA023526-03
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Marijuana Abuse and Dependence

Keywords

Marijuana; Treatment; Behavioral; Computer; Internet

Outcome Measures

Primary Outcomes (2)

• Consecutive Weeks of Marijuana Abstinence

  Longest period of marijuana abstinence achieved during the 12-week treatment period documented by urine testing and self-report.

  From the start of treatment through the end of the active treatment period, i.e., 12 weeks.

• 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).

  9 months (from the end of treatment to 9 months post-treatment).

Study Arms (3)

1

ACTIVE COMPARATOR

Therapist delivered cognitive behavioral treatment

Behavioral: Psychotherapy

2

EXPERIMENTAL

Computerized Cognitive Behavioral treatment

Behavioral: Computerized Psychotherapy

3

ACTIVE COMPARATOR

Motivational enhancement therapy

Behavioral: Motivational enhancement therapy

Interventions

Psychotherapy BEHAVIORAL

Nine session treatment

1

Computerized Psychotherapy BEHAVIORAL

Nine session computer delivered treatment

2

Motivational enhancement therapy BEHAVIORAL

Two session treatment

3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Geisel School of Medicine at Dartmouth

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Marijuana Abuse; Behavior

Interventions

Psychotherapy; Motivational Interviewing

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities; Directive Counseling; Counseling; Mental Health Services; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Alan J. Budney, PhD Principal Investigator
• Organization: Geisel School of Medicine at Dartmouth College

Alan.J.Budney@dartmouth.edu

855-290-2822

Study Officials

• Alan J Budney, Ph.D.

  Dartmouth College

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2008
• First Posted: January 16, 2008
• Study Start: November 1, 2008
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: December 4, 2013
• Results First Posted: December 4, 2013

Record last verified: 2013-12

Locations

US (1)