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).
The primary aim of this study is to examine cannabis use and rates of abstinence and relapse in individuals with moderate to severe Cannabis Use Disorder (CUD) after intensive 7-day contingency management (CM) procedure to reinforce abstinence from cannabis use. In addition, this study will evaluate the effect of CM with two sessions of brief MI on the severity of cannabis withdrawal signs during the first 7-days of CM treatment and then during the following month. The study will also focus on prospectively monitoring the sustenance of abstinence and time to lapse and relapse to cannabis use over a 90-day period, using ecological momentary assessment (EMA) via a smartphone-based application. An additional aim will be to evaluate changes in symptoms of CUD during the period following the 7-day using the diagnostic criteria of the DSM-5.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
49
Seven-day combined CM with two sessions of brief Motivation Interviewing (MI) followed by standardized individual drug counseling on cannabis use and relapse.
The Yale Stress Center: Yale University
New Haven, Connecticut, United States
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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: Slope Change 12 Weeks
Cannabis Withdrawal
The Cannabis Withdrawal Scale (Allsop et al., 2011):Participants will complete this questionnaire during weekly visits and during the EMA evening survey. The 19-item CWS has excellent reliability and has been validated in several previous cannabis abstinence, self-administration and treatment studies (Budney et al., 1999; Budney \& Moore, 2002; Haney, 2002). Participants will indicate if they experienced these symptoms, the degree to which they experienced them (0=Not at all to 10=Extremely), and how much of an impact it had on their lives (0=No at all to 10=Extremely). A summed scores, where a higher score means more difficulty, will be used as the outcome. The slope of change in the number of symptoms endorsed weekly will be the secondary outcome measure.
Time frame: Slope Change 12 Weeks