NCT03681353

Impact of Reduced Cannabis Use on Functional Outcomes

Completed NA Results posted Last updated 5 March 2021

What this trial tests

NA trial testing Mobile Contingency Management, active in Cannabis in 25 participants. Completed in 23 September 2020.

Timeline

4 April 2019

Primary endpoint
23 September 2020

23 September 2020

Quick facts

Lead sponsor	Duke University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	25
Start date	4 April 2019
Primary completion	23 September 2020
Estimated completion	23 September 2020
Sites	1 location across United States

Drugs / interventions tested

• Mobile Contingency Management, active

Conditions studied

• Cannabis — all drugs for Cannabis →
• Cannabis Use — all drugs for Cannabis Use →

Sponsor

Duke University

Who can join

Adults 18 to 70, any sex, with Cannabis or Cannabis Use. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Who Complete the Baseline Assessment Primary · Baseline

Adherence is defined as completing the baseline assessment

Group	Value	95% CI
Reduced Use Condition	18

Number of Participants Who Complete the 8-week Follow-up Assessment Primary · 8- week follow up

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

Group	Value	95% CI
Reduced Use Condition	18

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 Primary · 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

Group	Value	95% CI
Reduced Use Condition	8

Number of Participants Who Score Above Threshold on Treatment Acceptability Measure Primary · 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.

Group	Value	95% CI
Reduced Use Condition	18

Number of Participants Who Have ≥ 50% Reduction in Frequency of Cannabis Use Secondary · 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.

Group	Value	95% CI
Reduced Use Condition	12

Average Number of Days Since Last Cannabis Use Secondary · 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.

Group	Value	95% CI
Reduced Use Condition	6.95	± 9.55

Number of Participants Who Have ≥ 50% Reduction in Quantity of Cannabis Use Secondary · 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.

Group	Value	95% CI
Reduced Use Condition	18

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected for approximately eight weeks, from informed consent signature to the post-treatment visit.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Reduced Use Condition

Serious: 1/18 (6%)

Deaths: 0/18

Serious adverse events (1 terms)

Reaction	System	Reduced Use Condition
Psychiatric inpatient hospitalization	Psychiatric disorders	—

Other adverse events (2 terms — click to expand)

Reaction	System	Reduced Use Condition
Distress related to death in family	Psychiatric disorders	—
Broken arm	Musculoskeletal and connective tissue disorders	—

Most-reported serious reactions: Psychiatric inpatient hospitalization.

Data from ClinicalTrials.gov NCT03681353 adverse events section.

Sponsor's own description

Nearly 20 million Americans report use of cannabis in the past month, and heavy cannabis use has increased by nearly 60% in the U.S. since 2007. Heavy cannabis use is associated with lower educational attainment, reduced physical activity, and increased rates of addiction, unemployment, and neuropsychological deficits. Studies by the lab and others suggest that cannabis use is also associated with increased mental health symptoms and suicidal and nonsuicidal self-injury. In addition, cannabis is the illicit drug most strongly associated with drugged driving and traffic accidents, including fatal accidents. There is evidence that sustained abstinence from cannabis can lead to improvements in the functional outcomes of former users. However, he degree to which reductions in cannabis use might be associated with positive changes in functional outcomes is currently unknown. The overall objective of the present research is to use ecological momentary assessment (EMA), a real-time, naturalistic data collection method, to study the impact of reduced cannabis use on functional outcomes in heavy cannabis users. Contingency management (CM) will be used to promote reductions in frequency and quantity of cannabis use. CM is an intensive behavioral therapy that is highly effective at producing short-term reductions in illicit drug use. The investigators novel approach includes mobile technology to make CM more portable and feasible. The present research will use this technology in conjunction with state-of-the-art EMA methods to study the impact of reduced cannabis use on key functional outcomes. The investigators central hypothesis is that reductions in frequency and quantity of cannabis use will lead to positive changes in cannabis users' mental health, physical activity, working memory, health-related quality of life, and driving behavior.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.