Impact of Reduced Cannabis Use on Functional Outcomes

NCT03681353 | Completed Results

• 1 other identifier: Pro00100100
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cannabis; Cannabis Use

Outcome Measures

Primary Outcomes (4)

• Number of Participants Who Complete the Baseline Assessment

  Adherence is defined as completing the baseline assessment

  Baseline

• Number of Participants Who Complete the 8-week Follow-up Assessment

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

  8- week follow up

• 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

  Adherence is defined as completing 1 or more EMA assessments per day (total ≥56) for the duration of the 8-week EMA protocol

  8 week follow up

• Number of Participants Who Score Above Threshold on Treatment Acceptability Measure

  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.

  8-week posttreatment visit

Secondary Outcomes (3)

• Number of Participants Who Have ≥ 50% Reduction in Frequency of Cannabis Use

  Ad lib monitoring period (up to 2 weeks), 8-week posttreatment visit

• Average Number of Days Since Last Cannabis Use

  8-week posttreatment visit

• Number of Participants Who Have ≥ 50% Reduction in Quantity of Cannabis Use

  Ad lib monitoring period (up to 2 weeks), 8-week posttreatment visit

Study Arms (1)

Reduced Use Condition

EXPERIMENTAL

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

Interventions

Mobile Contingency Management, active BEHAVIORAL

Participants are provided monetary reinforcement for providing oral fluid test results that suggest they have reduced cannabis use.

Reduced Use Condition

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• cannabis use on ≥40 of past 90 days
• ability to speak and write fluent English
• years of age
• willingness to attempt to temporarily reduce cannabis use

You may not qualify if:

• expect to have an unstable medication regimen during the study
• are currently receiving non-study CUD treatment
• meet criteria for serious mental illness (e.g., bipolar disorder, schizophrenia)
• become imprisoned
• become hospitalized for psychiatric reasons
• become pregnant
• report imminent risk for suicide or homicide
• meet criteria for a substance use disorder other than CUD or tobacco

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27706, United States

Location

MeSH Terms

Conditions

Marijuana Abuse

Interventions

Exercise

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Angela Kirby, MS
• Organization: Duke University Medical Center

angela.kirby@duke.edu

919-286-0411

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2018
• First Posted: September 24, 2018
• Study Start: April 4, 2019
• Primary Completion: September 23, 2020
• Study Completion: September 23, 2020
• Last Updated: March 5, 2021
• Results First Posted: March 5, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)