Clinical trial NCT04567394: Cannabis Use Disorder Treatment Study
Official title: Treating Young Adult Cannabis Use Disorder with Text Message-Delivered Peer Network Counseling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cannabis Use Disorder, Mild
Cannabis Use Disorder, Moderate
Cannabis Use Disorder, Severe
Lead sponsor: The University of Tennessee, Knoxville
Sponsor class: OTHER
Collaborators: name: Colorado State University
First posted: 2020-09-28
Enrollment: 1077
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline in Tetrahydrocannabinol (Delta-9-THC-COOH) levels
timeFrame: Baseline, 1 month, 3 months, 6 months
measure: Change in Past 30-Day Cannabis Use
timeFrame: Baseline, 1 month, 3 months, 6 months
Secondary outcomes:
measure: Change in Environmental Risk Assessment
timeFrame: Baseline, 1 month, 3 months, 6 months
measure: Change in Young Adult Social Network Assessment
timeFrame: Baseline, 1 month, 3 months, 6 months
measure: Cost Measures
timeFrame: 6 months
Other outcomes:
Locations:
city: Fort Collins
country: United States
facility: Colorado State University
state: Colorado
city: Knoxville
country: United States
facility: University of Tennessee Knoxvile
state: Tennessee
Study officials:
affiliation: University of Tennessee, Knoxville
name: Michael J Mason, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Tennessee, Knoxville
name: J. Douglas Coatsworth, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: