CompletedPhase 2

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

United States144 participantsStarted 2016-06-01

Plain-language summary

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

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male or female; any race or ethnicity.
✓. Served in U.S. Military - any branch or operation.
✓. Subjects must be able to comprehend English.
✓. 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).
✓. Meet DSM-5 criteria for current (i.e., last month) PTSD.
✓. 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.
✓. Must consent to random assignment to doxazosin or placebo.
✓. Must consent to complete all treatment and follow-up visits.

Exclusion criteria

✕. Subjects meeting DSM-5 criteria for current bipolar affective disorders, as the study protocol may be therapeutically insufficient.
✕. 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.
✕. Individuals considered an immediate suicide risk or who are likely to require hospitalization during the course of the study.
✕. Previous treatment with doxazosin.
✕. 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.
✕. Women who are pregnant, nursing or not practicing an effective form of birth control.
✕. 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.
✕. Subjects with abnormal liver function test (LFTs) as evidenced by laboratory findings of SGOT or SGPT greater than two times normal.

What they're measuring

Clinician Administered PTSD Scale

Timeframe: 12 Weeks

PTSD Checklist (PCL-5)

Timeframe: 12 Weeks

Time Line Follow Back (TLFB)

Timeframe: 12 Weeks

Trial details

NCT IDNCT02500602

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2019-12-16

Results submitted2021-03-18

View on ClinicalTrials.gov More Posttraumatic Stress Disorder trials

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male or female; any race or ethnicity.
✓. Served in U.S. Military - any branch or operation.
✓. Subjects must be able to comprehend English.
✓. 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).
✓. Meet DSM-5 criteria for current (i.e., last month) PTSD.
✓. 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.
✓. Must consent to random assignment to doxazosin or placebo.
✓. Must consent to complete all treatment and follow-up visits.

Exclusion criteria

✕. Subjects meeting DSM-5 criteria for current bipolar affective disorders, as the study protocol may be therapeutically insufficient.
✕. 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.
✕. Individuals considered an immediate suicide risk or who are likely to require hospitalization during the course of the study.
✕. Previous treatment with doxazosin.
✕. 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.
✕. Women who are pregnant, nursing or not practicing an effective form of birth control.
✕. 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.
✕. Subjects with abnormal liver function test (LFTs) as evidenced by laboratory findings of SGOT or SGPT greater than two times normal.