Prazosin for Alcohol Use Disorder With Withdrawal Symptoms

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT04793685
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Alcohol Withdrawal

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Prazosin — DRUG
    Prazosin (16mg/day) versus Placebo comparator, with a 2 week titration period, 9 weeks at full dose and a 5-day taper in week 12.
  • 12-Step Facilitation with Relapse Prevention and Contingency Management — BEHAVIORAL
    12-Step Facilitation and relapse prevention weekly support and Contingency Management for each weekly appointment to support treatment attendance for all subjects.

Study Details

This is a Phase 2 single site randomized clinical trial (RCT) to be supported by a new NIH-NIAAA grant, R01-AA029113-01, to assess the efficacy of Prazosin (16mg/day) versus Placebo over a 12 week treatment period, followed by a 1- and 3- month assessments post-treatment for individuals with Alcohol Use Disorder (AUD) and history of past or current evidence of alcohol withdrawal symptoms. If medical detoxification is required for any patient, patients would be enrolled after medical detoxification. for those not requiring detoxification, they will be enrolled directly without any requirement of alcohol abstinence. All patients will be provided behavioral counseling weekly with a trained counselor to support recovery during the trial. Primary outcome will be percent of any heavy drinking days and secondary drinking outcomes will be percent of subjects with no heavy drinking days (PSNHDD), avg drinks per drinking day and %of any drinking drinking days as well as additional secondary outcomes of craving, mood and anxiety problems.

Key Dates

Start date
Jul 1, 2021
Status verified
Dec 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active Drug
    Prazosin (16mg/day) versus Placebo comparator, administered in t.i.d schedule, in capsules, over a 12 week period, with 2 weeks titration in weeks 1-2 and a 5-day taper in week 12.
  • Placebo Comparator: Placebo Drug
    Placebo for 12 weeks.

Primary Outcome Measure

Percent Heavy Drinking Days [ Time Frame: weeks 3 - 12 of full dose treatment ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
The Yale Stress Center: Yale UniversityNew HavenConnecticut06519
Rachel Hart, MS
[email protected]
203-737-4791
RAJITA SINHA
[email protected]
2037375805
Rajita Sinha, PhD (PRINCIPAL_INVESTIGATOR)
The Yale Stress Center: Yale UniversityNew HavenConnecticut06519
Rachel Hart, MS
[email protected]
203-737-4791
RAJITA SINHA, PHD
[email protected]
12037375805
Rajita Sinha, PhD (PRINCIPAL_INVESTIGATOR)

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The Yale Stress Center: Yale University· New Haven, CT

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