CAP: Doxazosin in the Treatment of Co-Occurring PTSD and Alcohol Use Disorders

• Status: Completed
• Trial end date: 2019-12-16
• Target enrollment: 0
• Participant gender: All

Summary

The proposed study will examine the efficacy of doxazosin in the treatment of PTSD and alcohol use disorder or substance use disorders.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of South Carolina; VA Office of Research and Development
• Collaborators: Medical University of South Carolina; Ralph H. Johnson VA Medical Center
• Treatments: Doxazosin

Criteria

Inclusion Criteria:

1. Male or female; any race or ethnicity.

2. Served in U.S. Military - any branch or operation.

3. Subjects must be able to comprehend English.

4. Meet criteria for current (i.e., last 6 months) Substance Use Disorder (SUD) using a modified version of the MINI 7.0 (i.e., must meet DSM-5 criteria for SUD in the past 6 months instead of 12 months).

5. Meet DSM-5 criteria for current (i.e., last month) PTSD.

6. Subjects taking psychotropic medications will be required to be maintained on a stable dose for at least four weeks before treatment initiation. This is because initiation or change of medications during the course of the trial may interfere with interpretation of results.

7. Must consent to random assignment to doxazosin or placebo.

8. Must consent to complete all treatment and follow-up visits.

Exclusion Criteria:

1. Subjects meeting DSM-5 criteria for current bipolar affective disorders, as the study protocol may be therapeutically insufficient.

2. Subjects experiencing significant withdrawal symptoms, as evidence by a score of 10 or above on the Clinical Institute Withdrawal Assessment of Alcohol (CIWA). These subject will be referred for clinical detoxification and may be re-assessed for study eligibility after medically supervised detoxification has been completed.

3. Individuals considered an immediate suicide risk or who are likely to require hospitalization during the course of the study.

4. Previous treatment with doxazosin.

5. Subjects on maintenance anxiolytic, antidepressant, or mood stabilizing medications which have been initiated during the past four weeks. If it is determined, based on clinical criteria, that a subject needs to be started on maintenance medications for anxiety, mood or psychotic symptoms during the course of the study, they may be discontinued from the treatment trial.

6. Women who are pregnant, nursing or not practicing an effective form of birth control.

7. Individuals with a history of or current medical illness including unstable angina, myocardial infarction, congestive heart failure or other cardiac condition, hypotension, renal or hepatic disorders, endocrine disorders, prostate or other cancer, pancreatitis, or a seizure disorder.

8. Subjects with abnormal liver function test (LFTs) as evidenced by laboratory findings of SGOT or SGPT greater than two times normal.

9. Subjects with a history of adverse reactions to quinazolines or other alpha-1-antagonists (such as allergic reactions, priapism, hepatitis, angioedema, or intraoperative floppy iris syndrome).

10. Individuals currently taking alpha blockers (terazosin, prazosin), hypnotics/benzodiazepines, atypical antipsychotics (olanzapine, quetiapine, risperidone, clozapine), alpha-2-agonists (Clonidine, methyldopa, tizanidine, guanfacine), conivaptan, boceprevir, idelalisib, PDE-5 inhibitors or alpha-1-antagonists, protease inhibitors (treatment of HIV), oral antifungals, alfuzosin, pazopanib, silodosin, tadalafil, or tamulosin.

11. MRI exclusions: Claustrophobia; tattoos above the shoulders after evaluation by MRI technician; permanent eyeliner or permanent artificial eyebrows; cardiac pacemaker; metal fragments in eye, skin, or body, including shrapnel; heart valve replacement; brain clips; venous umbrella; being a sheet-metal worker or welder; lifetime history of aneurysm surgery; intracranial bypass, renal, or aortic clips; prosthetic devices such as middle ear, eye, joint, or penile implants; joint replacements; non-removable hearing aid, neurostimulator, or insulin pump; shunts/stents; metal mesh/coil implants; metal plate/pin/screws/wires; or any other metal implants.