Marijuana Treatment Project 4

NCT ID: NCT02030665

Last Updated: 2019-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2018-04-30

Brief Summary

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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

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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.

Conditions

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Marijuana Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standardized MET plus CB (SMET-CB)

Motivational Enhancement plus Cognitive-Behavioral treatment

Group Type ACTIVE_COMPARATOR

Cognitive-Behavioral Treatment

Intervention Type BEHAVIORAL

Standard psychoeducational approach to coping skills training

SMET+ CM (SMET-CB-CM)

Motivational Enhancement plus CB treatment plus contingency management

Group Type EXPERIMENTAL

Contingency Management

Intervention Type BEHAVIORAL

Reinforcement provided contingent upon demonstration of negative drug tests

Individualized Assessment & Treatment (IATP)

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

Group Type EXPERIMENTAL

Individualized Assessment & Treatment

Intervention Type BEHAVIORAL

Tailored Cognitive-Behavioral Treatment based on detailed records of patient behavior

IATP + CM (IATP-CM).

Individualized Assessment and Treatment plus Contingency Management

Group Type EXPERIMENTAL

Contingency Management

Intervention Type BEHAVIORAL

Reinforcement provided contingent upon demonstration of negative drug tests

Individualized Assessment & Treatment

Intervention Type BEHAVIORAL

Tailored Cognitive-Behavioral Treatment based on detailed records of patient behavior

Interventions

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Contingency Management

Reinforcement provided contingent upon demonstration of negative drug tests

Intervention Type BEHAVIORAL

Individualized Assessment & Treatment

Tailored Cognitive-Behavioral Treatment based on detailed records of patient behavior

Intervention Type BEHAVIORAL

Cognitive-Behavioral Treatment

Standard psychoeducational approach to coping skills training

Intervention Type BEHAVIORAL

Other Intervention Names

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Positive Reinforcement IATP CBT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

UConn Health

OTHER

Sponsor Role lead

Responsible Party

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Mark Litt

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mark D Litt, PhD

Role: PRINCIPAL_INVESTIGATOR

UConn Health

Elise Kabela-Cormier, PhD

Role: STUDY_DIRECTOR

UConn Health

Locations

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University of Connecticut Health Center

Farmington, Connecticut, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34014689 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31318225 (View on PubMed)

Other Identifiers

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R01DA012728

Identifier Type: NIH

Identifier Source: secondary_id

View Link

12-174-3

Identifier Type: -

Identifier Source: org_study_id

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