Spironolactone in Alcohol Use Disorder (SAUD)

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
National Institute on Drug Abuse (NIDA)
Study ID
NCT05807139
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Placebo — OTHER
    Placebo
  • Spironolactone — DRUG
    Spironolactone and its matched placebo will be encapsulated into hard gelatin capsules, in same color, size and taste, to allow blinding. Participants will receive 2x50 mg/day, 2x100 mg, and 2x200 mg/day in three sessions (Stages); these Visits always occur in ascending order of dosage. In the remaining session, participants receive the placebo. Spironolactone is approved by the FDA, commercially available, and used in clinical practice for the treatment of hypertension, NYHA Class III-IV heart failure, edema in cirrhotic patients, and primary hyperaldosteronism. Comprehensive information about spironolactone, including its pharmacological properties, are provided in the Prescribing Information.

Study Details

Background: Alcohol use disorder (AUD) affects about 29.5 million people in the United States. Only 3 medicines have been approved by Food and Drug Administration to treat AUD. Researchers want to find better treatments for AUD. Animal studies found that a medicine called spironolactone, may decrease the amount of alcohol the animals drank. Spironolactone is approved to treat high blood pressure, or heart failure in people. It is not approved to treat AUD. Objective: To test a medicine (spironolactone) in people who sometimes drink excessive alcohol in order to understand how the body breaks down spironolactone and if there are any side effects in people who drink alcohol while taking this medicine. Eligibility: People aged 21 and older with AUD. Design: Participants will have 4 separate 7-day stays at a clinic in Baltimore over 2 months. Spironolactone is a capsule you swallow. Participants will take a capsule twice a day for 5 days during each clinic stay. During 1 of their 4 stays, they will take a placebo instead of the medicine. The placebo capsule looks just like the spironolactone capsule but contains no medicine. Participants will not know when they are taking the medicine or the placebo. Participants will not drink alcohol until day 6 of each clinic stay. Then they will be asked to drink alcohol in a bar-like area in the clinic. Their breath and blood alcohol levels and their well-being will be measured. Participants will undergo other tests in the clinic: A DEXA (dual energy X-ray absorptiometry) scan uses X-rays to measure bone density and muscle mass. Participants will lie on an open-top, padded table, then a small arm will scan the full length of their body. The radiation participants will get in this study is about the same as from one regular x-ray. Blood tests. Participants may feel some discomfort at the site of needle entry. Electrocardiogram. This test records the heart activity. Sensors are attached to the skin with stickers and removed after a few minutes. Urine tests. All urine will be collected over a 3-day period during each stay. We will measure the amount of urine, and different hormones and salts in the urine. Questionnaires and tasks. Participants will answer questions about their alcohol use. They will perform tasks to test mood, craving, mental and physical coordination, and how much they feel an effect from alcohol after drinking.

Key Dates

Start date
Jul 13, 2023
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Apr 30, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Placebo 1st visit
    stage 1: Placebostage 2: 2x50 mg/day spironolactonestage 3: 2x100 mg/day spironolactonestage4: 2x200 mg/day spironolactone
  • Experimental: Placebo 2nd visit
    stage 1: 2x50 mg/day spironolactonestage 2: Placebostage3: 2x100 mg/day spironolactonestage 4: 2x200 mg/day spironolactone
  • Experimental: Placebo 3rd visit
    stage1: 2x50 mg/day spironolactonestage 2: 2x100 mg/day spironolactonestage 3: Placebostage4: 2x200 mg/day spironolactone
  • Experimental: Placebo 4th visit
    Stage1: 2x50 mg/day spironolactoneStage 2: 2x100 mg/day spironolactonestage 3: 2x200 mg/day spironolactonestage 4: Placebo

Primary Outcome Measure

Describe steady-state PK of spironolactone in individuals with AUD, before and after oral alcohol administration. [ Time Frame: Before and after oral alcohol administration. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institute on Drug AbuseBaltimoreMaryland21224
Lorenzo Leggio, M.D.
[email protected]
240-478-1503
Masoumeh Dejman
[email protected]
(240) 987-8983

Find similar trials in Baltimore, MD

By condition
Substance use disorder
By specialty
Behavioral healthAddiction medicine
By research site
National Institute on Drug Abuse· Baltimore, MD

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