NCT04567394

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).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,077

participants targeted

Target at P75+ for not_applicable

Timeline
1mo left

Started Aug 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Aug 2019May 2026

Study Start

First participant enrolled

August 1, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 28, 2020

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

6.8 years

First QC Date

September 21, 2020

Last Update Submit

April 27, 2026

Conditions

Cannabis Use Disorder, MildCannabis Use Disorder, ModerateCannabis Use Disorder, Severe

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Change in Environmental Risk Assessment

    Baseline, 1 month, 3 months, 6 months

  • Change in Young Adult Social Network Assessment

    Baseline, 1 month, 3 months, 6 months

  • Cost Measures

    6 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Waitlist Control

NO INTERVENTION

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

Interventions

Peer Network Counseling-txtBEHAVIORAL

4-week text counseling program

Also known as: PNC-txt
Intervention

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Colorado State University

Fort Collins, Colorado, 80523, United States

Location

University of Tennessee Knoxvile

Knoxville, Tennessee, 37996, United States

Location

Related Publications (1)

  • Zaharakis N, Coatsworth JD, Riggs NR, Radford A, Rayburn S, Mennis J, Russell MA, Brown A, Mason MJ. Treating young adult cannabis use disorder with text message-delivered peer network counseling. Contemp Clin Trials. 2024 Sep;144:107635. doi: 10.1016/j.cct.2024.107635. Epub 2024 Jul 15.

    PMID: 39019156DERIVED

MeSH Terms

Conditions

Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Michael J Mason, Ph.D.

    University of Tennessee, Knoxville

    PRINCIPAL INVESTIGATOR

  • J. Douglas Coatsworth, Ph.D.

    University of Tennessee, Knoxville

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 21, 2020

First Posted

September 28, 2020

Study Start

August 1, 2019

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2026

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(2)