Marijuana Treatment Project 4 (MTP4)

This study is currently recruiting participants.
Verified January 2014 by University of Connecticut Health Center
Sponsor:
Information provided by (Responsible Party):
University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT02030665
First received: January 7, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted
  Purpose

Marijuana is the most commonly used illicit drug in the US, but treatment for marijuana dependence is not fully effective. In the current proposal we are exploring the idea that more tailored teaching of coping skills may result in improved outcomes for marijuana-dependence than those seen thus far.Participants will be 275 men and women meeting criteria for marijuana dependence and randomly assigned to 9 sessions of treatment in one of 4 treatment conditions: Standardized MET plus CB (SMET-CB); SMET+ CM (SMET-CB-CM); IATP; or IATP + CM (IATP-CM). Patients in all treatments will engage in ES via cell-phone for two weeks prior to treatment, for a weekly period during treatment, for another week after treatment has ended, and for two weekly periods at months 8 and 14. In the IATP conditions, the information gathered from the pretreatment and during-treatment ES periods will provide data for a functional analysis of patients' drug use and urges to use. It is hypothesized that IATP conditions will yield significantly better coping skills acquisition than SMET-CB conditions, both at posttreatment and at extended follow-ups, and that change in coping skills will predict better outcomes for the IATP conditions


Condition Intervention
Marijuana Dependence
Behavioral: Contingency Management
Behavioral: Individualized Assessment & Treatment
Behavioral: Cognitive-Behavioral Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Individualized Assessment and Treatment for Marijuana Dependence: Treatment Mechanisms

Resource links provided by NLM:


Further study details as provided by University of Connecticut Health Center:

Primary Outcome Measures:
  • Marijuana Use [ Time Frame: every 3 months ] [ Designated as safety issue: No ]
    Marijuana use measured in terms of Days of use in every 90-day period


Secondary Outcome Measures:
  • Coping Skills [ Time Frame: every 3 months ] [ Designated as safety issue: No ]
    Coping Skills measured using the Coping Skills Survey, administered every 3 months


Estimated Enrollment: 275
Study Start Date: February 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standardized MET plus CB (SMET-CB)
Motivational Enhancement plus Cognitive-Behavioral treatment
Behavioral: Cognitive-Behavioral Treatment
Standard psychoeducational approach to coping skills training
Other Name: CBT
Experimental: SMET+ CM (SMET-CB-CM)
Motivational Enhancement plus CB treatment plus contingency management
Behavioral: Contingency Management
Reinforcement provided contingent upon demonstration of negative drug tests
Other Name: Positive Reinforcement
Experimental: IATP
Individualized Assessment and Treatment Program; Cognitive-Behavioral Treatment based on in-depth field monitoring of patient behavior
Behavioral: Individualized Assessment & Treatment
Tailored Cognitive-Behavioral Treatment based on detailed records of patient behavior
Other Name: IATP
Experimental: IATP + CM (IATP-CM).
Individualized Assessment and Treatment plus Contingency Management
Behavioral: Contingency Management
Reinforcement provided contingent upon demonstration of negative drug tests
Other Name: Positive Reinforcement
Behavioral: Individualized Assessment & Treatment
Tailored Cognitive-Behavioral Treatment based on detailed records of patient behavior
Other Name: IATP

Detailed Description:

Marijuana is the most commonly used illicit drug in the US, but treatment for marijuana dependence is not fully effective. The most effective treatments to date have employed motivational enhancement (MET) plus cognitive-behavioral coping skills treatment (CB) and contingency management (CM) for abstinence. This proposal is a competitive renewal of our recently completed study to enhance coping and self-efficacy to improve marijuana outcomes in the long term. In the current proposal we are exploring the idea that more tailored teaching of coping skills may result in improved outcomes for marijuana-dependence than those seen thus far. The Individualized Assessment and Treatment Program (IATP) for marijuana dependent patients will employ experience sampling (ES) to determine the strengths and weaknesses of each patient in drug-use situations so that treatment can be tailored accordingly. Results from a pilot study indicated that IATP for alcohol dependent patients yielded better drinking outcomes at posttreatment than a packaged CB program (PCBT), that IATP patients reported greater use of coping skills than PCBT participants, and that posttreatment reports of coping skills were related to posttreatment drinking. Participants will be 275 men and women meeting criteria for marijuana dependence and randomly assigned to 9 sessions of treatment in one of 4 treatment conditions: Standardized MET plus CB (SMET-CB); SMET+ CM (SMET-CB-CM); IATP; or IATP + CM (IATP-CM). Patients in all treatments will engage in ES via cell-phone for two weeks prior to treatment, for a weekly period during treatment, for another week after treatment has ended, and for two weekly periods at months 8 and 14. In the IATP conditions, the information gathered from the pretreatment and during-treatment ES periods will provide data for a functional analysis of patients' drug use and urges to use. Therapists will use the information to address specific cognitions, affects, and behaviors that are adaptive and maladaptive, and will tailor a specific coping skills program with the patient. During-treatment experience sampling will allow adjustment of the treatment goals and procedures, making the treatment adaptive. In the SMET-CB conditions the experience sampling data will not be used in therapy, but will still provide in-vivo measures of drinking and coping skills. It is hypothesized that IATP conditions will yield significantly better coping skills acquisition than SMET-CB conditions, both at posttreatment and at extended follow-ups, and that change in coping skills will predict better outcomes for the IATP conditions. It is further predicted that the addition of CM to both IATP and SMET-CB will enhance short-term and long-term outcomes. The results will have implications for improved tailoring of treatment to patients' strength and deficits, and for the validity of the training of coping skills for relapse prevention. The data collected will shed light on the ways in which patients in treatment use coping skills in real-time contexts. Finally, the use of repeated ES periods will allow us to determine how treatment impacts thoughts, feelings and behaviors, and how these in turn affect outcome in the long and short term.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • at least 18 yrs old
  • meet DSM-IV criteria for Cannabis Dependence
  • be willing to accept random assignment to any of the 4 treatment conditions

Exclusion Criteria:

  • acute medical/psychiatric problems that require inpatient treatment (e.g., acute psychosis, severe depression, suicide/homicide risk)
  • reading ability below the fifth grade level
  • lack of reliable transportation
  • excessive commuting distance.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02030665

Contacts
Contact: Mark D Litt, PhD 860-679-4680 Litt@nso.uchc.edu
Contact: Elise Kabela-Cormier, PhD 860-679-2657 kabela@uchc.edu

Locations
United States, Connecticut
University of Connecticut Health Center Recruiting
Farmington, Connecticut, United States, 06030
Sponsors and Collaborators
University of Connecticut Health Center
Investigators
Principal Investigator: Mark D Litt, PhD University of Connecticut Health Center
Study Director: Elise Kabela-Cormier, PhD University of Connecticut Health Center
  More Information

Additional Information:
No publications provided

Responsible Party: University of Connecticut Health Center
ClinicalTrials.gov Identifier: NCT02030665     History of Changes
Other Study ID Numbers: NIDA-12728-11
Study First Received: January 7, 2014
Last Updated: January 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Connecticut Health Center:
Marijuana Dependence
Individualized treatment
Motivational Enhancement Treatment
Cognitive-Behavioral Treatment
Contingency Management

Additional relevant MeSH terms:
Marijuana Abuse
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 16, 2014