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Marijuana Treatment Project 4 (MTP4)

Primary Purpose

Marijuana Dependence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Contingency Management
Individualized Assessment & Treatment
Cognitive-Behavioral Treatment
Sponsored by
UConn Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Marijuana Dependence focused on measuring Marijuana Dependence, Individualized treatment, Motivational Enhancement Treatment, Cognitive-Behavioral Treatment, Contingency Management

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Connecticut Health Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Standardized MET plus CB (SMET-CB)

SMET+ CM (SMET-CB-CM)

Individualized Assessment & Treatment (IATP)

IATP + CM (IATP-CM).

Arm Description

Motivational Enhancement plus Cognitive-Behavioral treatment

Motivational Enhancement plus CB treatment plus contingency management

Individualized Assessment and Treatment Program; Cognitive-Behavioral Treatment based on in-depth field monitoring of patient behavior

Individualized Assessment and Treatment plus Contingency Management

Outcomes

Primary Outcome Measures

Marijuana Use
Marijuana use measured in terms of Days of use in every 90-day period

Secondary Outcome Measures

Coping Skills
Coping Skills measured using the Coping Skills Survey, administered every 3 months

Full Information

First Posted
January 7, 2014
Last Updated
June 19, 2019
Sponsor
UConn Health
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT02030665
Brief Title
Marijuana Treatment Project 4
Acronym
MTP4
Official Title
Individualized Assessment and Treatment for Marijuana Dependence: Treatment Mechanisms
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UConn Health
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Marijuana Dependence
Keywords
Marijuana Dependence, Individualized treatment, Motivational Enhancement Treatment, Cognitive-Behavioral Treatment, Contingency Management

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
198 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standardized MET plus CB (SMET-CB)
Arm Type
Active Comparator
Arm Description
Motivational Enhancement plus Cognitive-Behavioral treatment
Arm Title
SMET+ CM (SMET-CB-CM)
Arm Type
Experimental
Arm Description
Motivational Enhancement plus CB treatment plus contingency management
Arm Title
Individualized Assessment & Treatment (IATP)
Arm Type
Experimental
Arm Description
Individualized Assessment and Treatment Program; Cognitive-Behavioral Treatment based on in-depth field monitoring of patient behavior
Arm Title
IATP + CM (IATP-CM).
Arm Type
Experimental
Arm Description
Individualized Assessment and Treatment plus Contingency Management
Intervention Type
Behavioral
Intervention Name(s)
Contingency Management
Other Intervention Name(s)
Positive Reinforcement
Intervention Description
Reinforcement provided contingent upon demonstration of negative drug tests
Intervention Type
Behavioral
Intervention Name(s)
Individualized Assessment & Treatment
Other Intervention Name(s)
IATP
Intervention Description
Tailored Cognitive-Behavioral Treatment based on detailed records of patient behavior
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-Behavioral Treatment
Other Intervention Name(s)
CBT
Intervention Description
Standard psychoeducational approach to coping skills training
Primary Outcome Measure Information:
Title
Marijuana Use
Description
Marijuana use measured in terms of Days of use in every 90-day period
Time Frame
every 3 months
Secondary Outcome Measure Information:
Title
Coping Skills
Description
Coping Skills measured using the Coping Skills Survey, administered every 3 months
Time Frame
every 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark D Litt, PhD
Organizational Affiliation
UConn Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elise Kabela-Cormier, PhD
Organizational Affiliation
UConn Health
Official's Role
Study Director
Facility Information:
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34014689
Citation
Litt MD, Kadden RM, Tennen H, Dunn HK. Momentary coping and marijuana use in treated adults: Exploring mechanisms of treatment. J Consult Clin Psychol. 2021 Apr;89(4):264-276. doi: 10.1037/ccp0000633.
Results Reference
derived
PubMed Identifier
31318225
Citation
Litt MD, Kadden RM, Tennen H, Petry NM. Individualized assessment and treatment program (IATP) for cannabis use disorder: Randomized controlled trial with and without contingency management. Psychol Addict Behav. 2020 Feb;34(1):40-51. doi: 10.1037/adb0000491. Epub 2019 Jul 18.
Results Reference
derived

Learn more about this trial

Marijuana Treatment Project 4

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