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Alpha-1 Adrenergic Receptor Antagonist

Prazosin for Cannabis Use Disorder (ReCOUP Trial)

Phase 4
Recruiting
Led By Garth E Terry, MD, PhD
Research Sponsored by VA Puget Sound Health Care System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 to 80 years inclusive
Ability to complete self-assessments and other clinical assessments in English
Must not have
Persons of childbearing potential who are pregnant, planning to become pregnant, or nursing during the study period
Previously diagnosed but untreated severe sleep apnea
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial will study whether the drug prazosin, which is used to treat symptoms of PTSD, can also help reduce cannabis use disorder in people who have PTSD.

Who is the study for?
This trial is for adults aged 18-80 who use cannabis at least four days a week and want to reduce their usage. They must be in good health, not using substances other than tobacco or alcohol, and agree to birth control if applicable. Those with PTSD symptoms may benefit especially.
What is being tested?
The study tests Prazosin Hydrochloride's ability to help individuals with or without PTSD reduce cannabis overuse by treating symptoms like insomnia and nightmares that often lead them to use cannabis.
What are the potential side effects?
Prazosin may cause dizziness, headache, drowsiness, lack of energy, weakness, palpitations, nausea or vomiting. It can also potentially lead to low blood pressure upon standing up which might result in fainting.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 80 years old.
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I can complete health assessments in English.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant, planning to become pregnant, or nursing during the study.
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I have severe sleep apnea that has not been treated.
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I have used synthetic cannabinoids like Spice or K2 in the last 30 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acceptability of participation
Quantifying cannabis consumption
Recruitment
+1 more
Secondary study objectives
Treatment outcome (exploratory)

Side effects data

From 2016 Phase 1 trial • 20 Patients • NCT01999530
30%
Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Prazosin Hydrochloride

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Open-label prazosin treatmentExperimental Treatment1 Intervention
Open-label administration of prazosin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prazosin Hydrochloride
2013
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

VA Mental Illness Research, Education and Clinical CentersFED
1 Previous Clinical Trials
35 Total Patients Enrolled
VA Puget Sound Health Care SystemLead Sponsor
65 Previous Clinical Trials
224,764 Total Patients Enrolled
University of WashingtonOTHER
1,817 Previous Clinical Trials
1,914,362 Total Patients Enrolled

Media Library

Prazosin Hydrochloride (Alpha-1 Adrenergic Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT04721353 — Phase 4
Cannabis Use Disorder Research Study Groups: Open-label prazosin treatment
Cannabis Use Disorder Clinical Trial 2023: Prazosin Hydrochloride Highlights & Side Effects. Trial Name: NCT04721353 — Phase 4
Prazosin Hydrochloride (Alpha-1 Adrenergic Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04721353 — Phase 4
~0 spots leftby Dec 2024
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