Marijuana Abuse and Dependence Clinical Trial
Official title:
Development and Efficacy Test of Computerized Treatment for Marijuana Dependence
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.
| Status | Completed |
| Enrollment | 75 |
| Est. completion date | July 2012 |
| Est. primary completion date | July 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Geisel School of Medicine at Dartmouth | Lebanon | New Hampshire |
| Lead Sponsor | Collaborator |
|---|---|
| Dartmouth-Hitchcock Medical Center |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | No |
| Primary | 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). | No |