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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

Tracking Information
First Submitted Date  ICMJE September 20, 2018
First Posted Date  ICMJE September 24, 2018
Last Update Posted Date April 11, 2019
Actual Study Start Date  ICMJE April 4, 2019
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 20, 2018)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03681353 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 20, 2018)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Reduced Cannabis Use on Functional Outcomes
Official Title  ICMJE Impact of Reduced Cannabis Use on Functional Outcomes
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Cannabis
  • Cannabis Use
Intervention  ICMJE Behavioral: Mobile Contingency Management, active
Participants are provided monetary reinforcement for providing oral fluid test results that suggest they have reduced cannabis use.
Study Arms  ICMJE 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.
Intervention: Behavioral: Mobile Contingency Management, active
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 20, 2018)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2020
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03681353
Other Study ID Numbers  ICMJE Pro00100100
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: There is no plan to share individual participant data.
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Duke University
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP