Overview

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:
VA Office of Research and Development
Collaborator:
Medical University of South Carolina
Treatments:
Doxazosin
Ethanol
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.