Cannabis Use Disorder, MildNCT04567394
Cannabis Use Disorder Treatment Study
A study testing Peer Network Counseling-txt in people with Cannabis Use Disorder, Mild and Cannabis Use Disorder, Moderate, run by The University of Tennessee, Knoxville at 2 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Cannabis Use Disorder, Mild, Cannabis Use Disorder, Moderate, Cannabis Use Disorder, Severe
- What is being tested?
- Peer Network Counseling-txt
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,077 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2019to 31 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Colorado State University
Fort Collins, Colorado, 80523
University of Tennessee Knoxvile
Knoxville, Tennessee, 37996
About this study
Official title: 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).
Read the 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.
- Conditions
- Cannabis Use Disorder, Mild, Cannabis Use Disorder, Moderate, Cannabis Use Disorder, Severe
- Being tested
- Peer Network Counseling-txt
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer Network Counseling-txtBehavioural
Also called PNC-txt
4-week text counseling program
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Baseline, 1 month, 3 months, 6 months
Secondary outcomes (3)
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
Measured: 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.
Measured: Baseline, 1 month, 3 months, 6 months
Cost Measures
Cost of intervention implementation will be compared to typical treatment cost for cannabis use disorder
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start1 Aug 2019
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cannabis Use Disorder, MildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,077 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Tennessee, Knoxville
- Sponsor type
- University, hospital or other
- Collaborators
- Colorado State University
- Responsible party
- Principal investigator, Michael Mason, The University of Tennessee, Knoxville
- Investigators
- Michael J Mason, Ph.D., Principal investigator, University of Tennessee, KnoxvilleJ. Douglas Coatsworth, Ph.D., Principal investigator, University of Tennessee, Knoxville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04567394
- Sponsor's protocol ID
- 1R01DA044206-01A1
- Status last verified
- Apr 2026
- First submitted
- 21 Sep 2020
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mason MJ, Coatsworth JD, Riggs NR, Russell M, Mennis J, Zaharakis N, Brown A. Text message-delivered cannabis use disorder treatment with young adults: A large randomized clinical trial. J Subst Use Addict Treat. 2025 Mar;170:209611. doi: 10.1016/j.josat.2024.209611. Epub 2024 Dec 25.
PubMed 39730041Zaharakis 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.
PubMed 39019156
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Young Adult Cannabis Use Disorder With Text Message-Delivered Peer Network Counseling
- ClinicalTrials.gov ID
- NCT04567394
- Acronym / sponsor ID
- 1R01DA044206-01A1
- Conditions
- Cannabis Use Disorder, Mild, Cannabis Use Disorder, Moderate, Cannabis Use Disorder, Severe
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,077 participants (actual)
- Lead sponsor
- The University of Tennessee, KnoxvilleUniversity, hospital or other
- Collaborators
- Colorado State University
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 28 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Peer Network Counseling-txtParticipants 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. |
| Waitlist Control | No intervention | –Participants randomized to the waitlist control group will complete questionnaires at baseline, 1 month, 3 months, and 6 months. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer Network Counseling-txtAlso: PNC-txt4-week text counseling program | Behavioural | Intervention |
Primary outcome
Change from Baseline in Tetrahydrocannabinol (Delta-9-THC-COOH) levels
Time frame: Baseline, 1 month, 3 months, 6 months
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
Time frame: Baseline, 1 month, 3 months, 6 months
Past-30-day substance use (cannabis, alcohol, tobacco, other drugs) and consequences are measured using the Alcohol, Smoking and Substance Involvement Screening Test
3 secondary outcomes
Change in Environmental Risk Assessment
Time frame: Baseline, 1 month, 3 months, 6 months
Change in Young Adult Social Network Assessment
Time frame: Baseline, 1 month, 3 months, 6 months
Cost Measures
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Derived from this study: PubMed 39730041Mason MJ, Coatsworth JD, Riggs NR, Russell M, Mennis J, Zaharakis N, Brown A. Text message-delivered cannabis use disorder treatment with young adults: A large randomized clinical trial. J Subst Use Addict Treat. 2025 Mar;170:209611. doi: 10.1016/j.josat.2024.209611. Epub 2024 Dec 25.
- Derived from this study: PubMed 39019156Zaharakis 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael J Mason, Ph.D. principal investigator
University of Tennessee, Knoxville
J. Douglas Coatsworth, Ph.D. principal investigator
University of Tennessee, Knoxville
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer Network Counseling-txt in people with Cannabis Use Disorder, Mild and Cannabis Use Disorder, Moderate, run by The University of Tennessee, Knoxville at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Tetrahydrocannabinol (Delta-9-THC-COOH) levels (time frame: Baseline, 1 month, 3 months, 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04567394, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.