Cannabis Use Disorder Treatment Study

Cannabis Use Disorder, Moderate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04567394
• Other study ID #: 1R01DA044206-01A1
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 7, 2020
• Est. completion date: May 31, 2025

Study information

• Verified date: May 2024
• Source: The University of Tennessee, Knoxville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1077
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cannabis Use Disorder, Mild
• Cannabis Use Disorder, Moderate
• Cannabis Use Disorder, Severe
• Marijuana Abuse

Intervention

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

Locations

Country	Name	City	State
United States	Colorado State University	Fort Collins	Colorado
United States	University of Tennessee Knoxvile	Knoxville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
The University of Tennessee, Knoxville	Colorado State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	Cost Measures	Cost of intervention implementation will be compared to typical treatment cost for cannabis use disorder	6 months