CannabisNCT03681353
Impact of Reduced Cannabis Use on Functional Outcomes
A study testing Mobile Contingency Management, active 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, and increased rates of addiction, unemployment, and neuropsychological… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cannabis, Cannabis Use
- What is being tested?
- Mobile Contingency Management, active
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2019to 23 Sep 2020
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- cannabis use on ≥40 of past 90 days
- ability to speak and write fluent English
- 18-70 years of age
- willingness to attempt to temporarily reduce cannabis use
Who cannot join
- 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
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, 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.
Read the detailed 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. While there is evidence that sustained abstinence can lead to improvements in the functional outcomes of former users, the degree to which reductions in cannabis use alone (i.e., in the absence of sustained abstinence) might be associated with positive changes in functional outcomes is currently unknown. This is a critical gap in the literature, as many clinical 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 overall 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. EMA addresses several limitations of traditional assessment techniques by enhancing ecological validity, minimizing memory bias, and enabling examination of the impact of context on participants' behavior. 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. Moreover, the investigators have recently developed a novel approach that leverages mobile technology and recent developments in cannabis testing to make CM for cannabis more portable and feasible. The investigators have pilot-tested this approach with heavy cannabis users and found that it is an acceptable and feasible method to reduce their cannabis use. 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. 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, active
- 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 Management, activeBehavioural
Participants are provided monetary reinforcement for providing oral fluid test results that suggest they have reduced cannabis use.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Mobile Contingency Management, active |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Complete the Baseline Assessment
Adherence is defined as completing the baseline assessment
Measured: Baseline
Number of Participants Who Complete the 8-week Follow-up Assessment
Adherence is defined as completing the 8-week follow-up assessment
Measured: 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
Measured: 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.
Measured: 8-week posttreatment visit
Secondary outcomes (3)
Number of Participants Who Have ≥ 50% Reduction in Frequency of Cannabis Use
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.
Measured: Ad lib monitoring period (up to 2 weeks), 8-week posttreatment visit
Average Number of Days Since Last Cannabis Use
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.
Measured: 8-week posttreatment visit
Number of Participants Who Have ≥ 50% Reduction in Quantity of Cannabis Use
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.
Measured: Ad lib monitoring period (up to 2 weeks), 8-week posttreatment visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study start4 Apr 2019
- Primary completion23 Sep 2020
- Study completion23 Sep 2020
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 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
- NCT03681353
- Sponsor's protocol ID
- Pro00100100
- Status last verified
- Mar 2021
- First submitted
- 20 Sep 2018
- Last updated
- 5 Mar 2021
- 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 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Reduced Cannabis Use on Functional Outcomes
- ClinicalTrials.gov ID
- NCT03681353
- Acronym / sponsor ID
- Pro00100100
- Conditions
- Cannabis, Cannabis Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 4 Apr 2019 (actual)
- Primary completion
- 23 Sep 2020 (actual)
- Study completion
- 23 Sep 2020 (actual)
- First posted
- 24 Sep 2018 (actual)
- Results
- Posted 5 Mar 2021
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, 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.
Detailed 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. While there is evidence that sustained abstinence can lead to improvements in the functional outcomes of former users, the degree to which reductions in cannabis use alone (i.e., in the absence of sustained abstinence) might be associated with positive changes in functional outcomes is currently unknown. This is a critical gap in the literature, as many clinical 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 overall 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. EMA addresses several limitations of traditional assessment techniques by enhancing ecological validity, minimizing memory bias, and enabling examination of the impact of context on participants' behavior. 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. Moreover, the investigators have recently developed a novel approach that leverages mobile technology and recent developments in cannabis testing to make CM for cannabis more portable and feasible. The investigators have pilot-tested this approach with heavy cannabis users and found that it is an acceptable and feasible method to reduce their cannabis use. 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. 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reduced Use Condition | Experimental | Behavioral: Mobile Contingency Management, activeThis 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- cannabis use on ≥40 of past 90 days
- ability to speak and write fluent English
- 18-70 years of age
- willingness to attempt to temporarily reduce cannabis use
Key exclusion criteria (8 listed)
- 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
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 Management, activeParticipants are provided monetary reinforcement for providing oral fluid test results that suggest they have reduced cannabis use. | Behavioural | Reduced Use Condition |
Primary outcome
Number of Participants Who Complete the Baseline Assessment
Time frame: Baseline
Adherence is defined as completing the baseline assessment
Number of Participants Who Complete the 8-week Follow-up Assessment
Time frame: 8- week follow up
Adherence is defined as completing the 8-week follow-up assessment
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
Time frame: 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
Number of Participants Who Score Above Threshold on Treatment Acceptability Measure
Time frame: 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.
3 secondary outcomes
Number of Participants Who Have ≥ 50% Reduction in Frequency of Cannabis Use
Time frame: Ad lib monitoring period (up to 2 weeks), 8-week posttreatment visit
Average Number of Days Since Last Cannabis Use
Time frame: 8-week posttreatment visit
Number of Participants Who Have ≥ 50% Reduction in Quantity of Cannabis Use
Time frame: Ad lib monitoring period (up to 2 weeks), 8-week posttreatment visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2021.
- 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, active 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 4 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 5 Mar 2021. 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 5 Mar 2021). 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?
Number of Participants Who Complete the Baseline Assessment (time frame: Baseline). 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 5 Mar 2021.