Cannabis Use Disorder Treatment Study

Treating Young Adult Cannabis Use Disorder With Text Message-Delivered Peer Network Counseling

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Cannabis Use Disorder, Mild; Cannabis Use Disorder, Moderate; Cannabis Use Disorder, Severe
• Intervention / Treatment: Behavioral: Peer Network Counseling-txt

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 Type: Interventional
• Enrollment (Actual): 1077
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Fort Collins, Colorado, United States, 80523
      • Colorado State University
  • Tennessee
    • Knoxville, Tennessee, United States, 37996
      • University of Tennessee Knoxvile

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Tetrahydrocannabinol (Delta-9-THC-COOH) levels	Urine THC levels (50ng/mL, 100ng/mL, 200ng/mL, 300ng/mL) will provide a biological measure for current cannabis use.	Baseline, 1 month, 3 months, 6 months
Change in Past 30-Day Cannabis Use	Past-30-day substance use (cannabis, alcohol, tobacco, other drugs) and consequences are measured using the Alcohol, Smoking and Substance Involvement Screening Test	Baseline, 1 month, 3 months, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Environmental Risk Assessment	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	Baseline, 1 month, 3 months, 6 months
Change in Young Adult Social Network Assessment	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.	Baseline, 1 month, 3 months, 6 months
Cost Measures	Cost of intervention implementation will be compared to typical treatment cost for cannabis use disorder	6 months

Collaborators and Investigators

• Sponsor: The University of Tennessee, Knoxville
• Collaborators: 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 record dates

Study Major Dates

• Study Start (Actual): December 7, 2020
• Primary Completion (Anticipated): May 31, 2024
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: September 21, 2020
• First Submitted That Met QC Criteria: September 21, 2020
• First Posted (Actual): September 28, 2020

Study Record Updates

• Last Update Posted (Estimate): December 8, 2022
• Last Update Submitted That Met QC Criteria: December 7, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Substance-Related Disorders; Disease; Marijuana Abuse
• Other Study ID Numbers: 1R01DA044206-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No