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Impact of Reduced Cannabis Use on Functional Outcomes

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ClinicalTrials.gov Identifier: NCT03681353
Recruitment Status : Recruiting
First Posted : September 24, 2018
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Cannabis Cannabis Use Behavioral: Mobile Contingency Management, active Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Impact of Reduced Cannabis Use on Functional Outcomes
Actual Study Start Date : April 4, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arm Intervention/treatment
Experimental: Reduced Use Condition
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
Participants are provided monetary reinforcement for providing oral fluid test results that suggest they have reduced cannabis use.




Primary Outcome Measures :
  1. Number of participants who complete the baseline assessment [ Time Frame: Baseline ]
    Adherence is defined as completing the baseline assessment

  2. 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

  3. 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

  4. 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.


Secondary Outcome Measures :
  1. 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 ]
    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.

  2. Average number of days since last cannabis use [ Time Frame: 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.

  3. 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 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03681353


Contacts
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Contact: Nathan Kimbrel, Ph.D. 919-384-8582 ext 4054 nathan.kimbrel@duke.edu
Contact: Angela C Kirby, M.S. 919-286-0411 ext 5526 angela.kirby@duke.edu

Locations
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United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27706
Contact: Angela C Kirby, MS    919-286-0411 ext 5526      
Sponsors and Collaborators
Duke University

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03681353     History of Changes
Other Study ID Numbers: Pro00100100
First Posted: September 24, 2018    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share individual participant data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders