Back to resultsCannabis Use and Relapse After One Week of Contingency Management Therapy
Primary Purpose
Cannabis Dependence
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Contingency Management + Motivational Interviewing
Sponsored by
About this trial
This is an interventional treatment trial for Cannabis Dependence
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- The Yale Stress Center: Yale University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Contingency Management + Motivational Interviewing
Arm Description
Participants will complete a seven-day combined CM with two sessions of brief Motivation Interviewing (MI) followed by standardized individual drug counseling.
Outcomes
Primary Outcome Measures
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).
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).
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.
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.
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04202146
Brief Title
Cannabis Use and Relapse After One Week of Contingency Management Therapy
Official Title
Cannabis Use and Relapse After One Week of Contingency Management Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
July 15, 2018 (Actual)
Primary Completion Date
March 15, 2019 (Actual)
Study Completion Date
September 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Contingency Management + Motivational Interviewing
Arm Type
Experimental
Arm Description
Participants will complete a seven-day combined CM with two sessions of brief Motivation Interviewing (MI) followed by standardized individual drug counseling.
Intervention Type
Behavioral
Intervention Name(s)
Contingency Management + Motivational Interviewing
Intervention Description
Seven-day combined CM with two sessions of brief Motivation Interviewing (MI) followed by standardized individual drug counseling on cannabis use and relapse.
Primary Outcome Measure Information:
Title
Cannabis Use
Description
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
Title
Overall Drug Use
Description
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
Title
Cannabis Use Severity
Description
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
Title
Urine Toxicology for Quantitative THC levels
Description
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
Title
Urine Toxicology for Quantitative THC metabolites
Description
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
Secondary Outcome Measure Information:
Title
Cannabis Withdrawal
Description
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
Other Pre-specified Outcome Measures:
Title
Marijuana Intoxication
Description
The Marijuana Intoxication Assessment will be used to assess acute cannabis intoxication at each visit using a brief structured interview conducted by the trained research staff member. This 8-item will be measured at intake and during the first week. This is a screen to ensure compliance with study requirements.
Time Frame
Baseline and Week 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Facility Information:
Facility Name
The Yale Stress Center: Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
12. IPD Sharing Statement
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Cannabis Use and Relapse After One Week of Contingency Management Therapy
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