Marijuana Treatment Project 4

Marijuana Dependence Clinical Trial

— MTP4  

Official title:

Individualized Assessment and Treatment for Marijuana Dependence: Treatment Mechanisms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02030665
• Other study ID #: 12-174-3
• Secondary ID: R01DA012728
• Status: Completed
• Phase: N/A
• Start date: February 2013
• Est. completion date: April 2018

Study information

• Verified date: June 2019
• Source: UConn Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• at least 18 yrs old

• meet Diagnostic and Statistical Manual IV (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.

Related Conditions & MeSH terms

• Marijuana Abuse
• Marijuana Dependence

Intervention

Behavioral:
• Contingency Management
Reinforcement provided contingent upon demonstration of negative drug tests
• Individualized Assessment & Treatment
Tailored Cognitive-Behavioral Treatment based on detailed records of patient behavior
• Cognitive-Behavioral Treatment
Standard psychoeducational approach to coping skills training

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 Use	Marijuana use measured in terms of Days of use in every 90-day period	every 3 months
Secondary	Coping Skills	Coping Skills measured using the Coping Skills Survey, administered every 3 months	every 3 months