NCT02030665

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
198

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 8, 2014

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

June 21, 2019

Status Verified

June 1, 2019

Enrollment Period

5.2 years

First QC Date

January 7, 2014

Last Update Submit

June 19, 2019

Conditions

Keywords

Marijuana DependenceIndividualized treatmentMotivational Enhancement TreatmentCognitive-Behavioral TreatmentContingency Management

Outcome Measures

Primary Outcomes (1)

  • Marijuana Use

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

    every 3 months

Secondary Outcomes (1)

  • Coping Skills

    every 3 months

Study Arms (4)

Standardized MET plus CB (SMET-CB)

ACTIVE COMPARATOR

Motivational Enhancement plus Cognitive-Behavioral treatment

Behavioral: Cognitive-Behavioral Treatment

SMET+ CM (SMET-CB-CM)

EXPERIMENTAL

Motivational Enhancement plus CB treatment plus contingency management

Behavioral: Contingency Management

Individualized Assessment & Treatment (IATP)

EXPERIMENTAL

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

Behavioral: Individualized Assessment & Treatment

IATP + CM (IATP-CM).

EXPERIMENTAL

Individualized Assessment and Treatment plus Contingency Management

Behavioral: Contingency ManagementBehavioral: Individualized Assessment & Treatment

Interventions

Reinforcement provided contingent upon demonstration of negative drug tests

Also known as: Positive Reinforcement
IATP + CM (IATP-CM).SMET+ CM (SMET-CB-CM)

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

Also known as: IATP
IATP + CM (IATP-CM).Individualized Assessment & Treatment (IATP)

Standard psychoeducational approach to coping skills training

Also known as: CBT
Standardized MET plus CB (SMET-CB)

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Marijuana Abuse

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Mark D Litt, PhD

    UConn Health

    PRINCIPAL INVESTIGATOR
  • Elise Kabela-Cormier, PhD

    UConn Health

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 7, 2014

First Posted

January 8, 2014

Study Start

February 1, 2013

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

June 21, 2019

Record last verified: 2019-06

Locations