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Behavioral Intervention

Harm Reduction for PTSD (NOC Trial)

N/A
Recruiting
Led By Leslie Lundahl, PhD
Research Sponsored by Wayne State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
meet DSM-5 criteria for PTSD w/ Sx of at least 6 months duration
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, every 2 weeks for 12 weeks, 3, 6, 12 months post baseline
Awards & highlights

NOC Trial Summary

This trial is testing if reducing THC in regular cannabis smokers using a CM intervention can help PTSD symptoms in U.S. veterans.

Who is the study for?
This trial is for U.S. veterans with PTSD who regularly use cannabis, have an IQ score over 80, and can consent to participate. They must test positive for THC but not other drugs in urine screens and should not be seeking treatment for Cannabis Use Disorder or have serious psychotic/bipolar disorders or high suicide risk.Check my eligibility
What is being tested?
The study examines the effects of reducing THC consumption through a contingency management intervention on PTSD symptoms in veterans. It aims to understand if managing cannabis use can serve as a therapeutic strategy.See study design
What are the potential side effects?
Since this trial involves reducing THC use rather than administering a drug, typical medication side effects are not expected. However, participants may experience withdrawal symptoms such as irritability, sleep difficulties, decreased appetite, restlessness.

NOC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with PTSD and have had symptoms for at least 6 months.

NOC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, every 2 weeks for 12 weeks, 3, 6, 12 months post baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, every 2 weeks for 12 weeks, 3, 6, 12 months post baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Clinician-Administered PTSD Scale for DSM-5 Total Severity Score (CAPS-5)
Change in Columbia Suicide Severity Rating Scale (C-SSRS)
Post-Traumatic Stress Disorder
+1 more
Secondary outcome measures
Change in Beck Depression Inventory-II
Change in Brief Pain Inventory
Change in California Verbal Learning Test
+6 more

NOC Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: THC Reduction GroupExperimental Treatment1 Intervention
This group will be asked to reduce the THC content and increase CBD content of their cannabis products to study the effect of PTSD symptom severity.
Group II: Naturalistic GroupActive Control1 Intervention
This group will followed as they follow their naturalistic cannabis use.

Find a Location

Who is running the clinical trial?

Wayne State UniversityLead Sponsor
307 Previous Clinical Trials
108,564 Total Patients Enrolled
Leslie Lundahl, PhDPrincipal InvestigatorWayne State University
5 Previous Clinical Trials
140 Total Patients Enrolled

Media Library

Reduce THC Use (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05386862 — N/A
Post-Traumatic Stress Disorder Research Study Groups: THC Reduction Group, Naturalistic Group
Post-Traumatic Stress Disorder Clinical Trial 2023: Reduce THC Use Highlights & Side Effects. Trial Name: NCT05386862 — N/A
Reduce THC Use (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05386862 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the age threshold for this experiment include those over 45 years old?

"This trial's minimum age of enrollment is 19 and it caps at 69 years old."

Answered by AI

Is this trial currently accepting new participants?

"The search for participants is still ongoing, as evidenced by the clinicaltrials.gov data which indicates that this medical study went live on May 25th 2022 and was revised most recently on May 17th of the same year."

Answered by AI

How many participants have been accepted into this research project?

"Affirmative, the reports on clinicaltrials.gov declare that this medical study is currently seeking participants. It was first posted on May 25th 2022 and last updated on May 17th of the same year. The trial requires 215 patients to be enrolled from one healthcare facility."

Answered by AI

Which types of participants are ideal for this research?

"This trial is enlisting 215 individuals aged 19 to 69 that are suffering from suicidal ideations. To qualify, applicants must meet DSM-5 criteria for PTSD with symptoms persisting at least 6 months, be competent enough to provide informed consent, demonstrate an IQ score of greater than 80, have a history in the US Armed Forces and report cannabis use on more than 4 occasions per month as well as test positive for THC in urine drug screen."

Answered by AI

What outcome is this research attempting to attain?

"This clinical trial will track participants' Change in Clinician-Administered PTSD Scale for DSM-5 Total Severity Score (CAPS-5) from Baseline to 2 weeks, 12 weeks, 3 months 6 months and 12 months post baseline. Secondary outcomes include a change in General Health Survey (Short form 36), Wisconsin Card Sort Task and Quality of Life Inventory scores over the same time frame; all three are measured on a numerical scale with higher numbers indicating better study results."

Answered by AI

Who else is applying?

What state do they live in?
Michigan
California
How old are they?
< 18
18 - 65
What site did they apply to?
Tolan Park Medical Building
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
~129 spots leftby Dec 2026