Clinical trial NCT04202146: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cannabis Dependence
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2019-12-17
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Cannabis Use
timeFrame: Slope Change 12 Weeks
measure: Overall Drug Use
timeFrame: Slope Change 12 Weeks
measure: Cannabis Use Severity
timeFrame: Slope Change 12 Weeks
measure: Urine Toxicology for Quantitative THC levels
timeFrame: Slope Change 12 Weeks
measure: Urine Toxicology for Quantitative THC metabolites
timeFrame: Slope Change 12 Weeks
Secondary outcomes:
measure: Cannabis Withdrawal
timeFrame: Slope Change 12 Weeks
Other outcomes:
measure: Marijuana Intoxication
timeFrame: Baseline and Week 1
Locations:
city: New Haven
country: United States
facility: The Yale Stress Center: Yale University
state: Connecticut
Study officials:
References: