Trial Outcomes & Findings for Impact of Reduced Cannabis Use on Functional Outcomes (NCT NCT03681353)

NCT ID: NCT03681353

Last Updated: 2021-03-05

Results Overview

Adherence is defined as completing the baseline assessment

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 25 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2021-03-05

Participant Flow

Participant milestones

Measure	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. Mobile Contingency Management, active: Participants are provided monetary reinforcement for providing oral fluid test results that suggest they have reduced cannabis use.
Overall Study STARTED	25
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Measure	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. Mobile Contingency Management, active: Participants are provided monetary reinforcement for providing oral fluid test results that suggest they have reduced cannabis use.
Overall Study Lost to Follow-up	2
Overall Study Withdrawal by Subject	3
Overall Study withdrawn by PI	2

Baseline Characteristics

Impact of Reduced Cannabis Use on Functional Outcomes

Baseline characteristics by cohort

Measure	Reduced Use Condition n=18 Participants 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. Mobile Contingency Management, active: Participants are provided monetary reinforcement for providing oral fluid test results that suggest they have reduced cannabis use.
Age, Continuous	36.95 years STANDARD_DEVIATION 12.93 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	11 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	18 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Adherence is defined as completing the baseline assessment

Outcome measures

Measure

Reduced Use Condition n=18 Participants 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. 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

18 Participants

PRIMARY outcome

Timeframe: 8- week follow up

Adherence is defined as completing the 8-week follow-up assessment

Outcome measures

Measure

Reduced Use Condition n=18 Participants 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. 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 8-week Follow-up Assessment

18 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure

Reduced Use Condition n=18 Participants 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. 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 1 or More Ecological Momentary Assessments (EMA) Per Day (Total ≥56) for the Duration of the 8-week EMA Protocol

8 Participants

PRIMARY outcome

Timeframe: 8-week posttreatment visit

Acceptability of treatment will be measured by a questionnaire designed for use in this study. A single item measured acceptability of treatment, with a Likert scale (1-10) response in which 1=extremely unacceptable and 10=extremely acceptable. Threshold for acceptability is a score of 6 or greater.

Outcome measures

Measure

Reduced Use Condition n=18 Participants 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. 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 Score Above Threshold on Treatment Acceptability Measure

18 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Reduced Use Condition n=18 Participants 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. 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 Have ≥ 50% Reduction in Frequency of Cannabis Use

12 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Reduced Use Condition n=18 Participants 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. Mobile Contingency Management, active: Participants are provided monetary reinforcement for providing oral fluid test results that suggest they have reduced cannabis use.

Average Number of Days Since Last Cannabis Use

6.95 days Standard Deviation 9.55

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Reduced Use Condition n=18 Participants 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. 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 Have ≥ 50% Reduction in Quantity of Cannabis Use

18 Participants

Adverse Events

Reduced Use Condition

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure

Reduced Use Condition n=18 participants at risk 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. Mobile Contingency Management, active: Participants are provided monetary reinforcement for providing oral fluid test results that suggest they have reduced cannabis use.

Psychiatric disorders Psychiatric inpatient hospitalization

5.6% 1/18 • Number of events 1 • Adverse events were collected for approximately eight weeks, from informed consent signature to the post-treatment visit.

Other adverse events

Measure	Reduced Use Condition n=18 participants at risk 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. Mobile Contingency Management, active: Participants are provided monetary reinforcement for providing oral fluid test results that suggest they have reduced cannabis use.
Psychiatric disorders Distress related to death in family	5.6% 1/18 • Number of events 1 • Adverse events were collected for approximately eight weeks, from informed consent signature to the post-treatment visit.
Musculoskeletal and connective tissue disorders Broken arm	5.6% 1/18 • Number of events 1 • Adverse events were collected for approximately eight weeks, from informed consent signature to the post-treatment visit.

Additional Information

Angela Kirby, MS

Duke University Medical Center

Phone: 919-286-0411

Email: angela.kirby@duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place