Impact of Reduced Cannabis Use on Functional Outcomes (R33 Phase) (FOCUS)

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, increased rates of addiction and unemployment, and neuropsychological deficits. Studies suggest that cannabis use is also associated with increased mental health symptoms, drugged driving, and traffic accidents. While there is evidence that sustained abstinence can lead to improvements in the functional outcomes of former users, the degree to which reductions alone (i.e., not sustained abstinence) in cannabis use might be associated with positive changes in functional outcomes is unknown. This is a critical gap in the literature, as many interventions for cannabis and other drugs are associated with decreases in frequency and quantity of use, but fail to achieve an effect on overall abstinence rates. The objective of the present research is to use ecological momentary assessment (EMA), a real-time, naturalistic data collection method, to prospectively 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. We have recently developed a novel approach that leverages mobile technology and recent developments in cannabis testing. We have pilot-tested this approach with heavy cannabis users and found that it is an acceptable and feasible method. The present research will use this technology in conjunction with EMA methods to study the impact of reduced cannabis use on key functional outcomes. Our central hypothesis is that reductions in frequency and quantity of cannabis use will lead to positive changes in cannabis users' mental health, self-efficacy, physical activity, working memory, health-related quality of life, and driving behavior. The rationale for this research is that it will provide the first and only real-time data concerning the potential impact of reductions in cannabis use on functional outcomes. As such, the findings from the present research will directly inform ongoing efforts to include reductions in illicit drug use as a valid, clinically-meaningful outcome measure in clinical trials of pharmacotherapies for the treatment of substance use disorders.

Study Overview

• Status: Completed
• Conditions: Cannabis; Cannabis Use
• Intervention / Treatment: Behavioral: Mobile contingency management

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27706
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Report 40 or more days of cannabis use (other than ingested cannabis, i.e., edibles) in past 90 days
• Can speak and write fluent conversational English
• Are between 18 and 80 years of age
• Are willing to attempt to reduce frequency of cannabis use
• Complete at least 10 of the 14 nightly diaries during the ad lib phase of the study procedures.

Exclusion Criteria:

• Are expected to have an unstable medication regimen during the study
• Are currently receiving non-study treatment for cannabis use disorder
• Are pregnant or become pregnant
• Meet criteria for a serious mental illness (e.g., bipolar disorder, schizophrenia)
• Meet criteria for a substance use disorder other than nicotine or cannabis use disorders
• Are currently imprisoned or in psychiatric hospitalization or become imprisoned or in psychiatric hospitalization
• Report imminent risk for suicide or homicide
• Meet criteria for bio-verified sustained abstinence (i.e., all of their saliva tests are negative during the 6-week experimental phase of the study)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reduced Use Condition; Participants in the reduced use condition will be provided mobile contingency management, in which they are paid to provide marijuana saliva readings that suggest they have been abstinent from marijuana use.	Behavioral: Mobile contingency management; Mobile contingency management is a mobile-phone based behavioral therapy that provides positive reinforcement (i.e., money) for abstinence that is highly effective at reducing substance use.; Other Names: mCM
No Intervention: Control Condition; Participants in the control condition will be asked to provide marijuana saliva readings, but they are not paid for abstinent readings. Instead, their payments are yoked to the average amount of payment made by two participants in the reduced use condition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Mental Health Symptoms	Mental health symptoms will be measured by the 90-item Symptom Checklist (SCL-90). This measure has a scoring range of 0 to 360, with lower scores indicating lower distress related to mental health.	Baseline and post-treatment (approximately eight weeks)
Change in Self-reported Self-efficacy	Self-efficacy will be measured by the Marijuana Reduction Strategies Self-Efficacy Scale. This measure has a scoring range of 0 to 84, with higher scores indicating increased self-efficacy.	Baseline and post-treatment (approximately eight weeks)
Change in Physical Activity as Measured by the Leisure-Time Physical Activity Questionnaire	Physical activity will be measured using the Leisure-Time Physical Activity Questionnaire. Scores range from 0 to 99, with higher scores indicating increased physical activity.	Baseline and post-treatment (approximately eight weeks)
Change in Physical Activity as Measured by the International Physical Activity Questionnaire	Physical activity will be measured using a continuous score on the International Physical Activity Questionnaire. The score is calculated by multiplying metabolic equivalents times minutes per day times days per week; scores range from 0 to 13,440. Higher scores indicate increased physical activity.	Time Frame: Baseline and post-treatment (approximately eight weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Health-related Quality of Life, WHOQOL-BREF	Health-related quality of life will be measured with the World Health Organization Quality of Life Brief (WHOQOL-BREF). The measure has a scoring range of 0 to 100, with higher scores indicating a higher quality of life.	Baseline and post-treatment (approximately eight weeks)
Change in Visual Working Memory	Visual working memory will be measured by the Visual Working Memory (VWM) Index of Wechsler Memory Scale, which is comprised of the Symbol Span and Spatial Addition subtests, whose scores are added together to create a VWM score. Although this scale has no minimum or maximum score, higher scores indicate better visual working memory.	Baseline and post-treatment (approximately eight weeks)
Change in Auditory Working Memory	Auditory working memory will be measured by the Auditory Working Memory (AWM) Index of Wechsler Memory Scale, which is comprised of the Digit Span and Letter-Number Sequencing subtests, whose scores are added together to create a AWM score. Although this scale has no minimum or maximum score, higher scores indicate better auditory working memory.	Baseline and post-treatment (approximately eight weeks)
Change in Impulsivity as Measured by Delay Discounting (i.e., Iowa Gambling Task)	Impulsivity will be measured with a delay discounting task called the Iowa Gambling Task. Scores range from -100 to 100. Higher scores indicate more advantageous choices (i.e., lower impulsivity).	Baseline and post-treatment (approximately eight weeks)
Change in Impulsivity as Measured by the Balloon Analogue Risk Task	Impulsivity will be measured with the Balloon Analogue Risk Task. Scores range from 0 to 128, and higher scores indicate higher impulsivity.	Baseline and post-treatment (approximately eight weeks)
Change in Impulsivity as Measured by Self-report	Self-reported impulsivity will be measured with the Urgency, Premeditation (lack of), Perserverance (lack of), Sensation Seeking, Positive Urgency, Impulsive Behavior Scale (UPPS-P). The measure has a score range of 59 to 236. Higher scores indicate higher impulsivity.	Baseline and post-treatment (approximately eight weeks)
Change in Number of Days of Drugged Driving	Number of days of drugged driving in the past month will be self-reported by participants using a Timeline Follow-Back Interview.	Baseline and post-treatment (approximately eight weeks)

Collaborators and Investigators

• Sponsor: Duke University

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2021
• Primary Completion (Actual): November 22, 2023
• Study Completion (Actual): November 22, 2023

Study Registration Dates

• First Submitted: September 23, 2020
• First Submitted That Met QC Criteria: September 23, 2020
• First Posted (Actual): September 28, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: November 4, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Marijuana Abuse
• Other Study ID Numbers: PRO00100100_1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share individual participant data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No