Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Marijuana Treatment Project - 3 (MTP-3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00107588
Recruitment Status : Completed
First Posted : April 6, 2005
Last Update Posted : July 28, 2017
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Mark Litt, UConn Health

Tracking Information
First Submitted Date  ICMJE April 5, 2005
First Posted Date  ICMJE April 6, 2005
Last Update Posted Date July 28, 2017
Study Start Date  ICMJE February 2007
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2007)
  • Marijuana abstinence [ Time Frame: One-year follow-up period ]
  • Self-efficacy, use of coping skills, and treatment attendance [ Time Frame: During 2-month treatment period ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
  • Drug use
  • Addiction severity
Change History Complete list of historical versions of study NCT00107588 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2007)
Continuous abstinence will be predicted by (a) treatment attendance; (b) posttreatment self-efficacy for coping; and (c) use of coping skills [ Time Frame: One-year follow-up period ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Marijuana Treatment Project - 3
Official Title  ICMJE Contingency Management for Marijuana Dependence
Brief 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.
Detailed 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.
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 Dependence
Intervention  ICMJE
  • Behavioral: Reinforcement for homework completion
    Provides contingent reinforcement for engaging in homework activities designed to enhance coping skills
  • Behavioral: Reinforcement for Abstinence
    Provides contingent reinforcement for submitting marijuana-free urine specimen
  • Behavioral: Case Management
    Will control for the effect of therapist-client contact by providing supportive case management as an active control condition.
Study Arms  ICMJE
  • Experimental: Reinforcement for homework completion
    Intervention: Behavioral: Reinforcement for homework completion
  • Active Comparator: Reinforcement for Abstinence
    Intervention: Behavioral: Reinforcement for Abstinence
  • Active Comparator: Case Management
    Intervention: Behavioral: Case Management
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: July 27, 2017)
215
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
248
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
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 NCT00107588
Other Study ID Numbers  ICMJE NIDA-12728-06
R01DA012728-06 ( U.S. NIH Grant/Contract )
R01-12728-06
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mark Litt, UConn Health
Study Sponsor  ICMJE UConn Health
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Mark D Litt, Ph.D. UConn Health
PRS Account UConn Health
Verification Date July 2017

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