Trial Outcomes & Findings for Pilot Trial of Contingency Management for Long-Term Cannabis Abstinence (NCT NCT03786224)

Last Updated: 2024-08-02

Results Overview

Cannabis abstinence will be indexed by progressively decreasing quantitative levels (ng/mL) of 11-nor-delta-9-THC-9-carboxylic acid (THCCOOH), the primary cannabis metabolite, in urine. Residual cannabinoid excretion will be differentiated from new cannabis exposure using a statistical model developed by Schwilke and colleagues (2011). This model was empirically derived from urine CN-THCCOOH concentration ratios of consecutively collected specimen pairs (current specimen/prior specimen). This model takes into account the time between collection of specimens, which enhances the accuracy of prediction of new cannabis use. This formula yields an expected CN-THCCOOH ratio associated with specimen pairs during abstinence, and observed ratios that exceed this expected value are interpreted as new cannabis use.

Recruitment status

COMPLETED

Study phase

Target enrollment

6 participants

Primary outcome timeframe

Six months

Results posted on

2024-08-02

Participant Flow

Participant milestones

Participant milestones
Measure	Abstinent Contingency Management: Six months of cannabis abstinence will be incentivized using a standard contingency management approach involving an escalating schedule of payment for abstinence and attendance.
Overall Study STARTED	6
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Trial of Contingency Management for Long-Term Cannabis Abstinence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Abstinent n=6 Participants Contingency Management: Six months of cannabis abstinence will be incentivized using a standard contingency management approach involving an escalating schedule of payment for abstinence and attendance.
Age, Continuous	19 years STANDARD_DEVIATION 1.3 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 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	1 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	1 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants
Urine THCCOOH	281.9 ng/mL STANDARD_DEVIATION 262.6 • n=5 Participants

PRIMARY outcome

Timeframe: Six months

Population: 6 subjects enrolled in this pilot study and were included in the analysis. However, no participants completed data collection at the 6-month time point.

Outcome measures

Outcome measures
Measure	Abstinent n=6 Participants Contingency Management: Six months of cannabis abstinence will be incentivized using a standard contingency management approach involving an escalating schedule of payment for abstinence and attendance.
Continuous Abstinence Via Progressive Declines in Urine THCCOOH	NA ng/mL Standard Deviation NA No participants completed data collection at the 6-month time point.

Adverse Events

Abstinent

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Abstinent n=6 participants at risk Contingency Management: Six months of cannabis abstinence will be incentivized using a standard contingency management approach involving an escalating schedule of payment for abstinence and attendance.
Metabolism and nutrition disorders Loss of Appetitie	33.3% 2/6 • Number of events 8 • Adverse event data were collected over 6 months. Adverse events were collected at all study visits for all enrolled participants.
Injury, poisoning and procedural complications Skin Wound	16.7% 1/6 • Number of events 2 • Adverse event data were collected over 6 months. Adverse events were collected at all study visits for all enrolled participants.
Gastrointestinal disorders Indigestion	33.3% 2/6 • Number of events 2 • Adverse event data were collected over 6 months. Adverse events were collected at all study visits for all enrolled participants.
Infections and infestations Common Cold	50.0% 3/6 • Number of events 5 • Adverse event data were collected over 6 months. Adverse events were collected at all study visits for all enrolled participants.
Psychiatric disorders Worsening Depression	16.7% 1/6 • Number of events 1 • Adverse event data were collected over 6 months. Adverse events were collected at all study visits for all enrolled participants.
Psychiatric disorders Worsening Suicidal Ideation	16.7% 1/6 • Number of events 1 • Adverse event data were collected over 6 months. Adverse events were collected at all study visits for all enrolled participants.
Social circumstances Increased Stress	33.3% 2/6 • Number of events 10 • Adverse event data were collected over 6 months. Adverse events were collected at all study visits for all enrolled participants.
General disorders Difficulty Sleeping	50.0% 3/6 • Number of events 15 • Adverse event data were collected over 6 months. Adverse events were collected at all study visits for all enrolled participants.
Musculoskeletal and connective tissue disorders Soreness	16.7% 1/6 • Number of events 1 • Adverse event data were collected over 6 months. Adverse events were collected at all study visits for all enrolled participants.
Psychiatric disorders Increased Irritability	16.7% 1/6 • Number of events 4 • Adverse event data were collected over 6 months. Adverse events were collected at all study visits for all enrolled participants.
General disorders Hot flashes	16.7% 1/6 • Number of events 2 • Adverse event data were collected over 6 months. Adverse events were collected at all study visits for all enrolled participants.

Additional Information

Randi Schuster, PhD

Massachusetts General Hospital

Phone: 617-643-6673

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place