CannabisFOCUSNCT04567238
Impact of Reduced Cannabis Use on Functional Outcomes (R33 Phase)
A study testing Mobile contingency management in people with Cannabis and Cannabis Use, run by Duke University at 1 site in United States.
Trial 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, increased rates of addiction and unemployment, and neuropsychological deficits. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cannabis, Cannabis Use
- What is being tested?
- Mobile contingency management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2021to 22 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27706
About this study
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.
- Conditions
- Cannabis, Cannabis Use
- Being tested
- Mobile contingency management
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile contingency managementBehavioural
Also called mCM
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.
| Study group | Role | What they receive |
|---|---|---|
| Reduced Use Condition | Experimental | 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. Receives: Behavioral: Mobile contingency management |
| Control Condition | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Time Frame: Baseline and post-treatment (approximately eight weeks)
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and post-treatment (approximately eight weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start19 Mar 2021
- Primary completion22 Nov 2023
- Study completion22 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CannabisStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04567238
- Sponsor's protocol ID
- PRO00100100_1
- Acronym
- FOCUS
- Status last verified
- Nov 2024
- First submitted
- 23 Sep 2020
- Last updated
- 24 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Reduced Cannabis Use on Functional Outcomes (R33 Phase)
- ClinicalTrials.gov ID
- NCT04567238
- Acronym / sponsor ID
- FOCUS / PRO00100100_1
- Conditions
- Cannabis, Cannabis Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 19 Mar 2021 (actual)
- Primary completion
- 22 Nov 2023 (actual)
- Study completion
- 22 Nov 2023 (actual)
- First posted
- 28 Sep 2020 (actual)
- Results
- Posted 24 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reduced Use Condition | Experimental | Behavioral: Mobile contingency managementParticipants 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. |
| Control Condition | No intervention | –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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile contingency managementAlso: mCMMobile 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. | Behavioural | Reduced Use Condition |
Primary outcome
Change in Mental Health Symptoms
Time frame: Baseline and post-treatment (approximately eight weeks)
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.
Change in Self-reported Self-efficacy
Time frame: Baseline and post-treatment (approximately eight weeks)
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.
Change in Physical Activity as Measured by the Leisure-Time Physical Activity Questionnaire
Time frame: Baseline and post-treatment (approximately eight weeks)
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.
Change in Physical Activity as Measured by the International Physical Activity Questionnaire
Time frame: Time Frame: Baseline and post-treatment (approximately eight weeks)
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.
7 secondary outcomes
Change in Health-related Quality of Life, WHOQOL-BREF
Time frame: Baseline and post-treatment (approximately eight weeks)
Change in Visual Working Memory
Time frame: Baseline and post-treatment (approximately eight weeks)
Change in Auditory Working Memory
Time frame: Baseline and post-treatment (approximately eight weeks)
Change in Impulsivity as Measured by Delay Discounting (i.e., Iowa Gambling Task)
Time frame: Baseline and post-treatment (approximately eight weeks)
Change in Impulsivity as Measured by the Balloon Analogue Risk Task
Time frame: Baseline and post-treatment (approximately eight weeks)
Change in Impulsivity as Measured by Self-report
Time frame: Baseline and post-treatment (approximately eight weeks)
Change in Number of Days of Drugged Driving
Time frame: Baseline and post-treatment (approximately eight weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data.
Related trials for Cannabis
Not yet recruiting
Substance Use and Media Preferences
Substance Use Behavior, Cannabis Intoxication
RecruitingObservational study
Study of an Oral Fluid Testing Approach
Cannabis Use, Cannabis Intoxication
RecruitingPhase 3
Nabilone for Agitation Blinded Intervention Trial
Alzheimer Disease, Agitation
Not yet recruitingPhase 1
PK/PD of Vaping THC-containing Liquids vs. Smoked Cannabis
Cigarette Smoking-Related Carcinoma
Active, not recruitingPhase 1
Psilocybin-assisted Treatment for Cannabis Use Disorder
Cannabis Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile contingency management in people with Cannabis and Cannabis Use, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Mental Health Symptoms (time frame: Baseline and post-treatment (approximately eight weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.