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Impact of Reduced Cannabis Use on Functional Outcomes (R33 Phase) (FOCUS)

Primary Purpose

Cannabis, Cannabis Use

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile contingency management
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cannabis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)

Sites / Locations

  • Duke University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Reduced Use Condition

Control Condition

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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. Higher scores indicate increased physical activity.
Change in physical activity as measured by the Baecke Physical Activity Questionnaire
Physical activity will be measured using the Baecke Physical Activity Questionnaire. Scores range from 3 to 15, with higher scores indicating increased physical activity.

Secondary Outcome Measures

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 denoting a higher quality of life.
Change in visual working memory
Visual working memory will be measured by the Visual Working Memory Index of Wechsler Memory Scale, which is comprised of the Symbol Span and Spatial Addition subtests. Higher scores indicate improved visual working memory.
Change in auditory working memory
Auditory working memory will be measured by the Auditory Working Memory Index of Wechsler Memory Scale, which is comprised of the Digit Span and Letter-Number Sequencing subtests.
Change in impulsivity as measured by delay discounting
Impulsivity will be measured with a delay discounting task. Lower scores on the task indicate lower impulsivity.
Change in impulsivity as measured by the Iowa Gambling Task
Impulsivity will be measured with the Iowa Gambling Task. Higher scores indicate lower impulsivity.
Change in impulsivity as measured by the Balloon Analogue Risk Task
Impulsivity will be measured with the Balloon Analogue Risk Task. Higher scores indicate higher impulsivity.
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.
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.

Full Information

First Posted
September 23, 2020
Last Updated
October 12, 2023
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT04567238
Brief Title
Impact of Reduced Cannabis Use on Functional Outcomes (R33 Phase)
Acronym
FOCUS
Official Title
Impact of Reduced Cannabis Use on Functional Outcomes (R33 Phase)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 19, 2021 (Actual)
Primary Completion Date
October 20, 2023 (Anticipated)
Study Completion Date
October 20, 2023 (Anticipated)

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, 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.

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
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Reduced Use Condition
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Condition
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mobile contingency management
Other Intervention Name(s)
mCM
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in mental health symptoms
Description
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.
Time Frame
Baseline and post-treatment (approximately eight weeks)
Title
Change in self-reported self-efficacy
Description
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.
Time Frame
Baseline and post-treatment (approximately eight weeks)
Title
Change in physical activity as measured by the International Physical Activity Questionnaire
Description
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. Higher scores indicate increased physical activity.
Time Frame
Baseline and post-treatment (approximately eight weeks)
Title
Change in physical activity as measured by the Baecke Physical Activity Questionnaire
Description
Physical activity will be measured using the Baecke Physical Activity Questionnaire. Scores range from 3 to 15, with higher scores indicating increased physical activity.
Time Frame
Baseline and post-treatment (approximately eight weeks)
Secondary Outcome Measure Information:
Title
Change in health-related quality of life, WHOQOL-BREF
Description
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 denoting a higher quality of life.
Time Frame
Baseline and post-treatment (approximately eight weeks)
Title
Change in visual working memory
Description
Visual working memory will be measured by the Visual Working Memory Index of Wechsler Memory Scale, which is comprised of the Symbol Span and Spatial Addition subtests. Higher scores indicate improved visual working memory.
Time Frame
Baseline and post-treatment (approximately eight weeks)
Title
Change in auditory working memory
Description
Auditory working memory will be measured by the Auditory Working Memory Index of Wechsler Memory Scale, which is comprised of the Digit Span and Letter-Number Sequencing subtests.
Time Frame
Baseline and post-treatment (approximately eight weeks)
Title
Change in impulsivity as measured by delay discounting
Description
Impulsivity will be measured with a delay discounting task. Lower scores on the task indicate lower impulsivity.
Time Frame
Baseline and post-treatment (approximately eight weeks)
Title
Change in impulsivity as measured by the Iowa Gambling Task
Description
Impulsivity will be measured with the Iowa Gambling Task. Higher scores indicate lower impulsivity.
Time Frame
Baseline and post-treatment (approximately eight weeks)
Title
Change in impulsivity as measured by the Balloon Analogue Risk Task
Description
Impulsivity will be measured with the Balloon Analogue Risk Task. Higher scores indicate higher impulsivity.
Time Frame
Baseline and post-treatment (approximately eight weeks)
Title
Change in impulsivity as measured by self-report
Description
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.
Time Frame
Baseline and post-treatment (approximately eight weeks)
Title
Change in number of days of drugged driving
Description
Number of days of drugged driving in the past month will be self-reported by participants using a Timeline Follow-Back Interview.
Time Frame
Baseline and post-treatment (approximately eight weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nathan Kimbrel, PhD
Phone
919-286-0411
Ext
134054
Email
nathan.kimbrel@duke.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Angela C Kirby, MS
Phone
919-286-0411
Ext
175526
Email
angela.kirby@duke.edu
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27706
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angela C Kirby, MS
Phone
919-286-0411
Ext
5526

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 (R33 Phase)

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