Reducing Cannabis Overuse With Prazosin

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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 help control symptoms. Relief from PTSD insomnia, nightmares, anxiety, and preoccupying thoughts have been reported as troublesome symptoms targeted by cannabis users. Risks from cannabis use by individuals with PTSD have been reported. Chronic use of cannabis can lead to tolerance, requiring increased use for symptom relief, and withdrawal symptoms upon stopping. CUD is more frequent and severe in those with PTSD than those without. Many symptoms of cannabis withdrawal overlap with troubling symptoms of PTSD and thus may be interpreted as a relapse of PTSD symptoms. Those attempting to reduce or stop cannabis use may experience cannabis withdrawal symptoms including insomnia and distressing dreams, anxiety, irritability, and/or excessive sweating that they may misattribute to re-emerging or untreated PTSD symptoms.

Excessive brain adrenaline activity is arguably the best-described neurobiological contribution to the pathophysiology of PTSD. Prazosin, a drug that blocks the negative effects of brain adrenaline, has demonstrated effectiveness in robustly reducing PTSD-related nightmares and sleep disturbance in active duty Servicemembers and recently discharged combat Veterans in most, but not all, clinical trials, as well as in civilians with non-combat trauma. Clinically, the investigators have observed that several patients with PTSD using cannabis to treat insomnia and/or trauma-related nightmares and wanting to reduce their cannabis use were able to achieve reduction or cessation of cannabis use once they were treated with an effective dose of prazosin. Therefore, we have wondered if prazosin may provide sufficient treatment of PTSD symptoms otherwise targeted by cannabis, supporting those individuals' efforts to reduce cannabis use.

This open-label pilot study aims to study 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Washington
• Treatments: Prazosin

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.