Status:
COMPLETED
Reducing Cannabis Overuse With Prazosin
Lead Sponsor:
VA Puget Sound Health Care System
Collaborating Sponsors:
University of Washington
VA Mental Illness Research, Education and Clinical Centers
Conditions:
Cannabis Dependence
Posttraumatic Stress Disorder
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
Cannabis use disorder (CUD) is a significant and expanding health problem, and no FDA approved treatments are currently available. Persons with posttraumatic stress disorder (PTSD) may use cannabis to...
Detailed Description
This pilot study aims to assess the feasibility of prazosin as a treatment for CUD in individuals with or without comorbid PTSD, and to evaluate if additional research on a larger scale is warranted. ...
Eligibility Criteria
Inclusion
- Inclusion Criteria for all participants:
- Men, women, and persons of all races and ethnic backgrounds are eligible.
- Age 18 to 80 years inclusive
- Ability to complete self-assessments and other clinical assessments in English
- Meet criteria for CUD within the last 30 days
- Report a minimum of 4 days a week or more of cannabis use (as assessed by 30 day TLFB at screening visit)
- Have a positive cannabinoid urine test
- Be in good general health
- Persons of childbearing potential must agree to use an effective means of birth control.
- Inclusion Criteria for participants with CUD and PTSD:
- Have a confirmed diagnosis on the Mini-International Neuropsychiatric Interview (MINI).
- Exclusion Criteria for all participants:
- Presence of a cognitive disorder
- History of moderate or severe traumatic brain injury (mild traumatic brain injury is not exclusionary)
- Current or past 3 months substance use disorder of any substance other than cannabis or tobacco (e.g., AUD, opioid use disorder)
- Current and/or ongoing use of any substance other than cannabis, tobacco, or alcohol within the last 30 days
- Current and/or ongoing use of synthetic cannabinoids (e.g., Spice, K2) within the last 30 days
- Positive urine drug screen for any drug of abuse other than cannabis at screening visit
- Persons of childbearing potential who are pregnant, planning to become pregnant, or nursing during the study period
- Allergy or previous adverse reaction to prazosin or other alpha-1 adrenoceptor antagonist
- Previously diagnosed but untreated severe sleep apnea
- Psychiatric instability or severe situational life crises, including evidence of being actively suicidal or homicidal
- Any unstable medical illness that may place the participant at increased risk in the judgment of the clinician
- Potential participants who have been taking trazodone will undergo a 2-week washout period before beginning study treatment to reduce risk of priapism.
Exclusion
Key Trial Info
Start Date :
November 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2025
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04721353
Start Date
November 9 2020
End Date
June 1 2025
Last Update
June 15 2025
Active Locations (1)
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1
VA Puget Sound Health Care System
Seattle, Washington, United States, 98108