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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00107588
Other study ID # NIDA-12728-06
Secondary ID R01DA012728-06R0
Status Completed
Phase N/A
First received April 5, 2005
Last updated July 27, 2017
Start date February 2007
Est. completion date August 2012

Study information

Verified date July 2017
Source UConn Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this research is to improve treatment outcome for marijuana-dependent individuals. The current study builds on the findings of our prior NIDA-funded marijuana treatment study in which improved client outcomes were associated with greater treatment attendance, greater client self-efficacy, and greater use of coping skills. We will use a contingency management paradigm to provide tangible reinforcement for completing homework assignments that are designed to enhance coping skills. It is anticipated that this will result in greater homework compliance, leading to greater self-efficacy regarding one's ability to cope with high-risk situations. Improved self-efficacy will enhance the likelihood of employing coping skills in high-risk situations, thereby increasing the probability of achieving and maintaining abstinence.


Description:

Participants will receive an intervention combining one session of motivational enhancement therapy with eight sessions of cognitive-behavioral coping skills therapy (MET+CBT). A contingency management procedure will be added to this intervention, providing reinforcement for completion of homework, as verified by call-ins to an Interactive Voice Recording (IVR) system. Outcomes will be compared to an MET+CBT intervention in which reinforcement will be provided for marijuana-free urine specimens, and to a control group that receives Case Management. Recruitment of 234 marijuana-dependent participants will occur over a three-year period. They will be randomly assigned to one of the three 9-session interventions. Treatment will be individual, manualized, and provided on an outpatient basis. Pretreatment assessments will obtain baseline data; follow-up assessments at three-month intervals for one year will evaluate marijuana use outcomes, other drug or alcohol use, and psychosocial functioning. It is anticipated that the intervention in which completion of homework is reinforced will result in the best outcomes. The mechanisms by which the interventions result in behavior change will be the specific focus of attention in this study.


Recruitment information / eligibility

Status Completed
Enrollment 215
Est. completion date August 2012
Est. primary completion date April 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Cannabis dependence

- Willing to accept random assignment to interventions

Exclusion Criteria:

- Current dependence on alcohol or other drugs

- Problems that require inpatient hospitalization

- Reading ability below fifth grade level

- Lack of reliable transportation to treatment

- Excessive commuting distance

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Reinforcement for homework completion
Provides contingent reinforcement for engaging in homework activities designed to enhance coping skills
Reinforcement for Abstinence
Provides contingent reinforcement for submitting marijuana-free urine specimen
Case Management
Will control for the effect of therapist-client contact by providing supportive case management as an active control condition.

Locations

Country Name City State
United States University of Connecticut Health Center Farmington Connecticut

Sponsors (2)

Lead Sponsor Collaborator
UConn Health National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Marijuana abstinence One-year follow-up period
Primary Self-efficacy, use of coping skills, and treatment attendance During 2-month treatment period
Secondary Continuous abstinence will be predicted by (a) treatment attendance; (b) posttreatment self-efficacy for coping; and (c) use of coping skills One-year follow-up period
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