Cannabis Use and Relapse After One Week of Contingency Management Therapy

NCT04202146 | Completed DMC

• 1 other identifier: 2000023188
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the effects of a seven-day combined contingency management (CM) with two sessions of brief Motivation Interviewing (MI) followed by standardized individual drug counseling on cannabis use and relapse in the following 90-day period in individuals with moderate to severe Cannabis Use Disorder (DSM-5).

Conditions

Cannabis Dependence

Outcome Measures

Primary Outcomes (5)

• Cannabis Use

  The Structured Clinical Interview for DSM-V (SCID-II) will be used to ascertain DSM-5 Axis 1 psychiatric and substance abuse diagnoses (First, et al., 2015) and specifically to determine presence/absence of DSM-5 Cannabis Use Disorder (CUD). The SCID-II interview for cannabis use will be administered at intake and weeks 4, 8, and 12 to measure changes in problematic cannabis use. The outcome will be the slope of change over study day in daily quantity of use and the percent use days per week. In addition, we will measure the percent of individuals who experienced a relapse throughout the study by week 12 (3 days of use weekly or 3 consecutive days of use).

  Slope Change 12 Weeks

• Overall Drug Use

  The Time-Line Follow-Back Interview will also be used to assess cannabis, alcohol, other drugs and nicotine use in the previous ninety days, during the study and during follow-up. This is a reliable experimenter-administered assessment (Sobell and Sobell, 1992), which uses a calendar prompt to facilitate recall of drug use during a targeted period, and well-validated in alcohol and drug abuse treatment studies (Fals-Stewart et al., 2000). This questionnaire will be administered at intake and weekly. The outcome will be the slope of change over study day in daily quantity of use and the percent use days per week. In addition, we will measure the percent of individuals who experienced a relapse throughout the study by week 12 (3 days of use weekly or 3 consecutive days of use).

  Slope Change 12 Weeks

• Cannabis Use Severity

  The Cannabis Use Disorder Identification Test-Revised (CUDIT) is an 8-item scale that will be used to quantify the severity of cannabis use over the past six-months (Adamson et al., 2010). This questionnaire will be administered at intake and weeks 4, 8, and 12. A summed score is used as an outcome where higher equals more cannabis-related problems.

  Slope Change 12 Weeks

• Urine Toxicology for Quantitative THC levels

  A urine drug screen will be given at each visit during week 1 to reinforce using CM for cannabis abstinence and monitor progressive reduction in THC levels, and at each visit during the duration of the study to assess levels of THC for determination of the primary clinical outcome of cannabis relapse. The slope of change over weeks 1 through 12 in quantitative THC levels and metabolites will be the outcome measure.

  Slope Change 12 Weeks

• Urine Toxicology for Quantitative THC metabolites

  A urine drug screen will be given at each visit during week 1 to reinforce using CM for cannabis abstinence and monitor progressive reduction in THC levels, and at each visit during the duration of the study to assess levels of THC for determination of the primary clinical outcome of cannabis relapse. The slope of change over weeks 1 through 12 in quantitative THC levels and metabolites will be the outcome measure.

  Slope Change 12 Weeks

Secondary Outcomes (1)

• Cannabis Withdrawal

  Slope Change 12 Weeks

Other Outcomes (1)

• Marijuana Intoxication

  Baseline and Week 1

Study Arms (1)

Contingency Management + Motivational Interviewing

EXPERIMENTAL

Participants will complete a seven-day combined CM with two sessions of brief Motivation Interviewing (MI) followed by standardized individual drug counseling.

Behavioral: Contingency Management + Motivational Interviewing

Interventions

Contingency Management + Motivational Interviewing BEHAVIORAL

Seven-day combined CM with two sessions of brief Motivation Interviewing (MI) followed by standardized individual drug counseling on cannabis use and relapse.

Contingency Management + Motivational Interviewing

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Body Mass Index (BMI) less than 32;
• Good health as verified by screening examination;
• Able to read English and complete study evaluations;
• Able to provide informed written and verbal consent;
• CUD sample must meet DSM-5 criteria for CUD as assessed using SCID-I and have positive cannabis urine toxicology screens on admission to study, with weekly 3 or more days of self-reported cannabis use.

You may not qualify if:

• Meet current DSM-5 criteria for dependence on another psychoactive substance or alcohol, excluding nicotine and mild Alcohol Use Disorder
• Current use of opiates or history of opiate abuse/dependence;
• Regular use of anticonvulsants, sedatives/hypnotics, prescription analgesics, other antihypertensives, anti-arrythmics, antiretroviral medications, tricyclic antidepressants, SSRI's, naltrexone, antabuse;
• Psychotic or otherwise severely psychiatrically disabled (i.e., suicidal, homicidal, current mania);
• Significant underlying medical conditions such as a history of seizure disorder, cerebral, renal, thyroid or cardiac pathology which in the opinion of study physician would preclude subjects from fully cooperating or be of potential harm during the study; a known history of Hepatitis B, C, or HIV infection;
• Any psychotic disorder or current Axis I psychiatric symptoms (excluding anxiety disorders) requiring specific attention, including need for psychiatric medications
• Women who are pregnant, nursing or refuse to use a reliable form of birth control (as assessed by pregnancy urine test during initial intake appointment; and
• Traumatic brain injury or extended loss of consciousness.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

The Yale Stress Center: Yale University

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Marijuana Abuse

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: December 17, 2019
• Study Start: July 15, 2018
• Primary Completion: March 15, 2019
• Study Completion: September 15, 2019
• Last Updated: November 11, 2021

Record last verified: 2021-11

Locations

US (1)