Impact of Reduced Cannabis Use on Functional Outcomes
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|ClinicalTrials.gov Identifier: NCT03681353|
Recruitment Status : Recruiting
First Posted : September 24, 2018
Last Update Posted : April 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cannabis Cannabis Use||Behavioral: Mobile Contingency Management, active||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Impact of Reduced Cannabis Use on Functional Outcomes|
|Actual Study Start Date :||April 4, 2019|
|Estimated Primary Completion Date :||June 1, 2020|
|Estimated Study Completion Date :||June 1, 2020|
Experimental: Reduced Use Condition
This arm includes six weeks of mobile contingency management treatment administered via a smart-phone based application (mobile CM), in which participants are provided monetary reinforcement for reducing cannabis use.
Behavioral: Mobile Contingency Management, active
Participants are provided monetary reinforcement for providing oral fluid test results that suggest they have reduced cannabis use.
- Number of participants who complete the baseline assessment [ Time Frame: Baseline ]Adherence is defined as completing the baseline assessment
- Number of participants who complete the 8-week follow-up assessment [ Time Frame: 8- week follow up ]Adherence is defined as completing the 8-week follow-up assessment
- Number of participants who complete 1 or more Ecological Momentary Assessments (EMA) per day (total ≥56) for the duration of the 8-week EMA protocol [ Time Frame: 8 week follow up ]Adherence is defined as completing 1 or more EMA assessments per day (total ≥56) for the duration of the 8-week EMA protocol
- Number of participants who score above threshold on Treatment Acceptability Measure [ Time Frame: 8-week posttreatment visit ]Acceptability of treatment will be measured by a questionnaire designed for use in this study.
- Number of participants who have ≥ 50% reduction in frequency of cannabis use [ Time Frame: Ad lib monitoring period (up to 2 weeks), 8-week posttreatment visit ]To evaluate if this milestone has been met, the investigators will calculate the percentage reduction in bioverified abstinent days by comparing the ad lib monitoring period to the mobile CM period.
- Average number of days since last cannabis use [ Time Frame: 8-week posttreatment visit ]Investigators will use count-adjusted (i.e., negative binomial or Poisson) MLM to model the equivalent number of joints/gram smoked on a given day as a function of days since last use.
- Number of participants who have ≥ 50% reduction in quantity of cannabis use [ Time Frame: Ad lib monitoring period (up to 2 weeks), 8-week posttreatment visit ]To evaluate if this milestone has been met, the investigators will calculate the percentage reduction in overall cannabis quantity by comparing the ad lib monitoring period to the mobile CM period.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03681353
|Contact: Nathan Kimbrel, Ph.D.||919-384-8582 ext firstname.lastname@example.org|
|Contact: Angela C Kirby, M.S.||919-286-0411 ext email@example.com|
|United States, North Carolina|
|Duke University Medical Center||Recruiting|
|Durham, North Carolina, United States, 27706|
|Contact: Angela C Kirby, MS 919-286-0411 ext 5526|