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Cannabis Use Disorder Treatment Study

Primary Purpose

Cannabis Use Disorder, Mild, Cannabis Use Disorder, Moderate, Cannabis Use Disorder, Severe

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Peer Network Counseling-txt
Sponsored by
The University of Tennessee, Knoxville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cannabis Use Disorder, Mild

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Colorado State University
  • University of Tennessee Knoxvile

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Waitlist Control

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

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

Full Information

First Posted
September 21, 2020
Last Updated
December 7, 2022
Sponsor
The University of Tennessee, Knoxville
Collaborators
Colorado State University
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1. Study Identification

Unique Protocol Identification Number
NCT04567394
Brief Title
Cannabis Use Disorder Treatment Study
Official Title
Treating Young Adult Cannabis Use Disorder With Text Message-Delivered Peer Network Counseling
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 7, 2020 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Tennessee, Knoxville
Collaborators
Colorado State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Use Disorder, Mild, Cannabis Use Disorder, Moderate, Cannabis Use Disorder, Severe

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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.
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1077 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist Control
Arm Type
No Intervention
Arm Description
Participants randomized to the waitlist control group will complete questionnaires at baseline, 1 month, 3 months, and 6 months.
Intervention Type
Behavioral
Intervention Name(s)
Peer Network Counseling-txt
Other Intervention Name(s)
PNC-txt
Intervention Description
4-week text counseling program
Primary Outcome Measure Information:
Title
Change from Baseline in Tetrahydrocannabinol (Delta-9-THC-COOH) levels
Description
Urine THC levels (50ng/mL, 100ng/mL, 200ng/mL, 300ng/mL) will provide a biological measure for current cannabis use.
Time Frame
Baseline, 1 month, 3 months, 6 months
Title
Change in Past 30-Day Cannabis Use
Description
Past-30-day substance use (cannabis, alcohol, tobacco, other drugs) and consequences are measured using the Alcohol, Smoking and Substance Involvement Screening Test
Time Frame
Baseline, 1 month, 3 months, 6 months
Secondary Outcome Measure Information:
Title
Change in Environmental Risk Assessment
Description
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
Time Frame
Baseline, 1 month, 3 months, 6 months
Title
Change in Young Adult Social Network Assessment
Description
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.
Time Frame
Baseline, 1 month, 3 months, 6 months
Title
Cost Measures
Description
Cost of intervention implementation will be compared to typical treatment cost for cannabis use disorder
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 to 25 years old. use of cannabis three or more days during a typical week. a score of at least eight on the Cannabis Use Disorder Identification Test-Revised a urine specimen positive for cannabis metabolites. a score of at least two on the Mini International Neuropsychiatric Interview: Version 7.0.2 for DSM-V, Substance Use Disorder must live in Tennessee or Colorado Exclusion Criteria: substance abuse treatment during the past three months. lack of access to a text-capable phone. unable or unwilling to commit to six months of follow-up. not fluent in English.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J Mason, Ph.D.
Organizational Affiliation
University of Tennessee, Knoxville
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
J. Douglas Coatsworth, Ph.D.
Organizational Affiliation
University of Tennessee, Knoxville
Official's Role
Principal Investigator
Facility Information:
Facility Name
Colorado State University
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80523
Country
United States
Facility Name
University of Tennessee Knoxvile
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37996
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Cannabis Use Disorder Treatment Study

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