search
Back to results

Impact of Reduced Cannabis Use on Functional Outcomes

Primary Purpose

Cannabis, Cannabis Use

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile Contingency Management, active
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cannabis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Reduced Use Condition

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of Participants Who Complete the Baseline Assessment
Adherence is defined as completing the baseline assessment
Number of Participants Who Complete the 8-week Follow-up Assessment
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
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
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
September 20, 2018
Last Updated
March 4, 2021
Sponsor
Duke University
search

1. Study Identification

Unique Protocol Identification Number
NCT03681353
Brief Title
Impact of Reduced Cannabis Use on Functional Outcomes
Official Title
Impact of Reduced Cannabis Use on Functional Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
April 4, 2019 (Actual)
Primary Completion Date
September 23, 2020 (Actual)
Study Completion Date
September 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis, Cannabis Use

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reduced Use Condition
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Mobile Contingency Management, active
Intervention Description
Participants are provided monetary reinforcement for providing oral fluid test results that suggest they have reduced cannabis use.
Primary Outcome Measure Information:
Title
Number of Participants Who Complete the Baseline Assessment
Description
Adherence is defined as completing the baseline assessment
Time Frame
Baseline
Title
Number of Participants Who Complete the 8-week Follow-up Assessment
Description
Adherence is defined as completing the 8-week follow-up assessment
Time Frame
8- week follow up
Title
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
Description
Adherence is defined as completing 1 or more EMA assessments per day (total ≥56) for the duration of the 8-week EMA protocol
Time Frame
8 week follow up
Title
Number of Participants Who Score Above Threshold on Treatment Acceptability Measure
Description
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.
Time Frame
8-week posttreatment visit
Secondary Outcome Measure Information:
Title
Number of Participants Who Have ≥ 50% Reduction in Frequency of Cannabis Use
Description
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.
Time Frame
Ad lib monitoring period (up to 2 weeks), 8-week posttreatment visit
Title
Average Number of Days Since Last Cannabis Use
Description
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.
Time Frame
8-week posttreatment visit
Title
Number of Participants Who Have ≥ 50% Reduction in Quantity of Cannabis Use
Description
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.
Time Frame
Ad lib monitoring period (up to 2 weeks), 8-week posttreatment visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27706
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share individual participant data.

Learn more about this trial

Impact of Reduced Cannabis Use on Functional Outcomes

We'll reach out to this number within 24 hrs