Using Prazosin to Help Reduce Cannabis Overuse

Pilot Study to Assess the Feasibility of Prazosin for Cannabis Use Disorder in Individuals With or Without Post-traumatic Stress Disorder

This study is testing if prazosin can help people who want to reduce their cannabis use, especially those with or without PTSD.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: VA Puget Sound Health Care System (Federal)
• Locations: 1 site (Seattle, Washington)
• Trial ID: NCT04721353 on ClinicalTrials.gov

What this trial studies

This pilot study evaluates the feasibility of using prazosin as a treatment for cannabis use disorder (CUD) in individuals, particularly those with or without comorbid posttraumatic stress disorder (PTSD). The study aims to recruit 20 treatment-seeking participants who have been using cannabis frequently and assess their ability to tolerate prazosin over a 12-week open-label treatment period. Researchers will measure cannabis use and associated clinical outcomes, while also focusing on recruitment and retention strategies for future larger studies. The study seeks to address the lack of FDA-approved treatments for CUD, especially in the context of PTSD.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 80 who meet the criteria for cannabis use disorder and have been using cannabis at least four days a week.

Not a fit: Patients with cognitive disorders or those with a history of substance use disorders other than cannabis or tobacco may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for individuals struggling with cannabis dependence, particularly those with PTSD.

How similar studies have performed: While this approach is novel in the context of cannabis use disorder, previous studies have shown promise in using prazosin for other conditions, indicating potential for success.

Eligibility criteria

Inclusion Criteria for all participants:

1. Men, women, and persons of all races and ethnic backgrounds are eligible.
2. Age 18 to 80 years inclusive
3. Ability to complete self-assessments and other clinical assessments in English
4. Meet criteria for CUD within the last 30 days
5. Report a minimum of 4 days a week or more of cannabis use (as assessed by 30 day TLFB at screening visit)
6. Have a positive cannabinoid urine test
7. Be in good general health
8. Persons of childbearing potential must agree to use an effective means of birth control.

   Inclusion Criteria for participants with CUD and PTSD:
9. Have a confirmed diagnosis on the Mini-International Neuropsychiatric Interview (MINI).

Exclusion Criteria for all participants:

1. Presence of a cognitive disorder
2. History of moderate or severe traumatic brain injury (mild traumatic brain injury is not exclusionary)
3. Current or past 3 months substance use disorder of any substance other than cannabis or tobacco (e.g., AUD, opioid use disorder)
4. Current and/or ongoing use of any substance other than cannabis, tobacco, or alcohol within the last 30 days
5. Current and/or ongoing use of synthetic cannabinoids (e.g., Spice, K2) within the last 30 days
6. Positive urine drug screen for any drug of abuse other than cannabis at screening visit
7. Persons of childbearing potential who are pregnant, planning to become pregnant, or nursing during the study period
8. Allergy or previous adverse reaction to prazosin or other alpha-1 adrenoceptor antagonist
9. Previously diagnosed but untreated severe sleep apnea
10. Psychiatric instability or severe situational life crises, including evidence of being actively suicidal or homicidal
11. Any unstable medical illness that may place the participant at increased risk in the judgment of the clinician
12. Potential participants who have been taking trazodone will undergo a 2-week washout period before beginning study treatment to reduce risk of priapism.

Where this trial is running

Seattle, Washington

• VA Puget Sound Health Care System — Seattle, Washington, United States (Recruiting)

Study contacts

• Principal investigator: Garth E Terry, MD, PhD — University of Washington
• Study coordinator: Federica Dennis

Conditions Cannabis Dependence; Posttraumatic Stress Disorder; Cannabis Use Disorder; Prazosin; Cannabis