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Cannabis Use Disorder Treatment Study

Sponsor
The University of Tennessee, Knoxville (Other)
Overall Status
Recruiting
CT.gov ID
NCT04567394
Collaborator
Colorado State University (Other)
1,000
Enrollment
2
Locations
2
Arms
42.7
Anticipated Duration (Months)
500
Patients Per Site
11.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to test a text-delivered counseling program to stop or reduce cannabis use among young adults (ages 18 to 25).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Peer Network Counseling-txt
 Phase 2

Detailed Description

After being informed about the study and potential risks, participants will complete online screening assessments. Those who are determined to be eligible via online screening will complete a urine drug screen to confirm eligibility. Once eligibility is confirmed, participants will be randomized either to the intervention group or to the wait-list control group. Those who are randomized to the intervention group will receive the 4-week text intervention via smartphone and complete assessments (including urine drug screens) at baseline, 1 month, 3 months, and 6 months. Those who are randomized to the wait-list control group will only complete the assessments (including urine drug screens) at baseline, 1 month, 3 months, and 6 months. Participants who are initially assigned to the wait-list control group can choose to receive the text intervention once their 6-month participation is complete.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants are randomized 1:1 to the intervention or waitlist control. Participants who complete the 6 months of waitlist control will then have the opportunity to receive the intervention.Participants are randomized 1:1 to the intervention or waitlist control. Participants who complete the 6 months of waitlist control will then have the opportunity to receive the intervention.
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Treating Young Adult Cannabis Use Disorder With Text Message-Delivered Peer Network Counseling
Actual Study Start Date :
Dec 7, 2020
Anticipated Primary Completion Date :
May 31, 2024
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

Participants randomized to the Intervention group will complete questionnaires at baseline, 1 month, 3 months, and 6 months and will receive 4 weeks of the PNC-txt intervention.

Behavioral: Peer Network Counseling-txt
4-week text counseling program
Other Names:
  • PNC-txt

    		•
    No Intervention: Waitlist Control

    Participants randomized to the waitlist control group will complete questionnaires at baseline, 1 month, 3 months, and 6 months.

    Outcome Measures

    Primary Outcome Measures

    1. Change from Baseline in Tetrahydrocannabinol (Delta-9-THC-COOH) levels [Baseline, 1 month, 3 months, 6 months]

      Urine THC levels (50ng/mL, 100ng/mL, 200ng/mL, 300ng/mL) will provide a biological measure for current cannabis use.

    2. Change in Past 30-Day Cannabis Use [Baseline, 1 month, 3 months, 6 months]

      Past-30-day substance use (cannabis, alcohol, tobacco, other drugs) and consequences are measured using the Alcohol, Smoking and Substance Involvement Screening Test

    Secondary Outcome Measures

    1. Change in Environmental Risk Assessment [Baseline, 1 month, 3 months, 6 months]

      Participants will report using the Ecological Momentary Assessment reporting about Craving (0=none-10= intense), Cannabis Use (0=none-10= a lot), Mood (0=very good-10= very depressed), and Stress (0=no stress-10 = very stressed) on a 10 point scale for each item

    2. Change in Young Adult Social Network Assessment [Baseline, 1 month, 3 months, 6 months]

      Participants report information on each their 3 closest friends, representing their egocentric network. Individual friend scores are totaled based on all 8 risky and prosocial items (2-9). Thus, each peer's score has a potential range from -32 to 32, with greater scores indicating a healthier relationship. The total peer network health scores is based on the sum of all 24 risky and prosocial items across all three friends. Assuming three peers per participant, total network quality scores may range from -96 to 96, with lower scores indicating greater network risk and higher scores indicating greater network protection.

    3. Cost Measures [6 months]

      Cost of intervention implementation will be compared to typical treatment cost for cannabis use disorder

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 25 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. 18 to 25 years old.

    2. use of cannabis three or more days during a typical week.

    3. a score of at least eight on the Cannabis Use Disorder Identification Test-Revised

    4. a urine specimen positive for cannabis metabolites.

    5. a score of at least two on the Mini International Neuropsychiatric Interview: Version 7.0.2 for DSM-V, Substance Use Disorder

    6. must live in Tennessee or Colorado

    Exclusion Criteria:

    1. substance abuse treatment during the past three months.

    2. lack of access to a text-capable phone.

    3. unable or unwilling to commit to six months of follow-up.

    4. not fluent in English.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Colorado State University Fort Collins Colorado United States 80523
    2 University of Tennessee Knoxvile Knoxville Tennessee United States 37996

    Sponsors and Collaborators

    • The University of Tennessee, Knoxville
    • Colorado State University

    Investigators

    • Principal Investigator: Michael J Mason, Ph.D., University of Tennessee, Knoxville
    • Principal Investigator: J. Douglas Coatsworth, Ph.D., University of Tennessee, Knoxville

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Michael Mason, Principal Investigator, The University of Tennessee, Knoxville
    ClinicalTrials.gov Identifier:
    NCT04567394
    Other Study ID Numbers:
    • 1R01DA044206-01A1
    First Posted:
    Sep 28, 2020
    Last Update Posted:
    May 19, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Disease
    Marijuana Abuse

    Study Results

    No Results Posted as of May 19, 2021