Alcohol Use Disorder Clinical Trial
Official title:
Doxazosin in the Treatment of Co-occuring PTSD and Alcohol Use Disorder
NCT number | NCT02492334 |
Other study ID # | 3733318 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | July 2016 |
Est. completion date | December 16, 2019 |
Verified date | December 2020 |
Source | Medical University of South Carolina |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study will test the efficacy of doxazosin, a long-acting and selective alpha-1 adrenergic antagonist, as compared to placebo in reducing PTSD symptomatology and alcohol use severity.
Status | Completed |
Enrollment | 144 |
Est. completion date | December 16, 2019 |
Est. primary completion date | November 13, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. Male or female; any race or ethnicity; age 21 to 65 years old. 2. U.S. military veteran. 3. Score of > 21 on the Mini Mental Status Exam. 4. Subjects must be able to comprehend English. 5. Meet DSM-5 criteria for current (i.e., last 6 months) alcohol use disorder (AUD). 6. Meet DSM-5 criteria for current (i.e., last 6 months) PTSD. 7. Enrolled in the VAMC Substance Abuse Treatment Clinic (SATC) program. 8. Subjects taking psychotropic medications will be required to be maintained on a stable dose for at least eight weeks before treatment initiation. 9. Must consent to random assignment to doxazosin or placebo. 10. Must consent to complete all treatment and follow-up visits. 11. Must live within 50 miles of the Ralph H. Johnson VAMC in Charleston, SC. Exclusion Criteria: 1. DSM-5 criteria for a history of or current psychotic or bipolar affective disorders, current eating disorder, as the study protocol may be therapeutically insufficient. 2. DSM-5 criteria for another substance use disorder, except caffeine or nicotine, within the past 12 months. 3. 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. 4. Individuals considered an immediate suicide risk based on the Columbia Suicide Severity rating Scale (C-SSRS) or who are likely to require hospitalization during the course of the study. 5. Previous treatment with doxazosin. 6. 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 will be discontinued from the treatment trial. 7. Women who are pregnant, nursing or not practicing an effective form of birth control. 8. Individuals with a history of or current medical illness including unstable angina, myocardial infarction, congestive heart failure or other cardiac condition, hypotension or hypertension, renal or hepatic disorders, endocrine disorders, prostate or other cancer, pancreatitis, or a seizure disorder. 9. Subjects with abnormal liver function test (LFTs) as evidenced by laboratory findings of SGOT or SGPT greater than two times normal. 10. 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). 11. Individuals currently taking medications to treat hypertension, trazodone, hypnotics/benzodiazepines, mirtazapine, atypical antipsychotics, alpha-2-agonists, prazosin, conivaptan, boceprevir, fusidic acid, idelalisib, PDE-5 inhibitors or alpha-1-antagonists. 12. MRI exclusions: Claustrophobia; tattoos above shoulders; permanent eyeliner or 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; 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. |
Country | Name | City | State |
---|---|---|---|
United States | Addiction Sciences Division-Medical University of South Carolina | Charleston | South Carolina |
Lead Sponsor | Collaborator |
---|---|
Medical University of South Carolina | Ralph H. Johnson VA Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PTSD symptoms | Clinician Administered PTSD Scale | 12 weeks | |
Primary | Alcohol use severity | Time Line Follow Back | 12 weeks | |
Secondary | Characterize the underlying pathophysiology of comorbid PTSD/AUD and prognostic indicators of treatment responses | fMRI | Baseline |
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