Spironolactone in Alcohol Use Disorder (SAUD)
- Registration Number
- NCT05807139
- Lead Sponsor
- National Institute on Drug Abuse (NIDA)
- Brief Summary
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.
- Detailed Description
Study Description:
This study will examine pharmacokinetic (PK) and pharmacodynamic (PD) parameters of spironolactone and alcohol, during concomitant oral administration (0, 100, 200, 400 mg/day spironolactone PO), and test the safety and tolerability of spironolactone, co-administered with alcohol, in individuals with alcohol use disorder (AUD).
Objectives:
Our objective is to assess PK and PD parameters during spironolactone-alcohol co-administration, in individuals with AUD. We will also test the safety, tolerability, and potential drug-alcohol interaction.
Endpoints:
Primary endpoint:
Spironolactone and alcohol PK during concomitant administration (0, 100, 200, and 400 mg/day spironolactone).
Secondary endpoints:
1. Assessment of subjective and cognitive effects of acute alcohol administration during concomitant spironolactone treatment (0, 100, 200, and 400 mg/day).
2. Number and severity of adverse events (AEs) experienced, compared between placebo (0 mg/day) and all three spironolactone doses (100, 200, 400 mg/day).
3. PK characteristic of spironolactone active metabolites, canrenone, 7-alpha-thiomethylspirolactone (TMS) and 6beta- hydroxy-7alpha-thiomethylspirolactone (HTMS), before and after administration of alcohol.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo 2nd visit Placebo stage 1: 2x50 mg/day spironolactonestage 2: Placebostage3: 2x100 mg/day spironolactonestage 4: 2x200 mg/day spironolactone Placebo 1st visit Placebo stage 1: Placebostage 2: 2x50 mg/day spironolactonestage 3: 2x100 mg/day spironolactonestage4: 2x200 mg/day spironolactone Placebo 3rd visit Placebo stage1: 2x50 mg/day spironolactonestage 2: 2x100 mg/day spironolactonestage 3: Placebostage4: 2x200 mg/day spironolactone Placebo 4th visit Placebo Stage1: 2x50 mg/day spironolactoneStage 2: 2x100 mg/day spironolactonestage 3: 2x200 mg/day spironolactonestage 4: Placebo Placebo 1st visit Spironolactone stage 1: Placebostage 2: 2x50 mg/day spironolactonestage 3: 2x100 mg/day spironolactonestage4: 2x200 mg/day spironolactone Placebo 2nd visit Spironolactone stage 1: 2x50 mg/day spironolactonestage 2: Placebostage3: 2x100 mg/day spironolactonestage 4: 2x200 mg/day spironolactone Placebo 3rd visit Spironolactone stage1: 2x50 mg/day spironolactonestage 2: 2x100 mg/day spironolactonestage 3: Placebostage4: 2x200 mg/day spironolactone Placebo 4th visit Spironolactone Stage1: 2x50 mg/day spironolactoneStage 2: 2x100 mg/day spironolactonestage 3: 2x200 mg/day spironolactonestage 4: Placebo
- Primary Outcome Measures
Name Time Method Describe steady-state PK of spironolactone in individuals with AUD, before and after oral alcohol administration. Before and after oral alcohol administration. PK characteristics of spironolactone (e.g., total concentration, peak concentration, elimination half-life) before (day 5) and after (day 6) oral alcohol administration.
Describe alcohol PK during concomitant spironolactone use 12 hours after oral alcohol administration PK characteristics of alcohol (e.g., blood alcohol concentrations, time for elimination) during concomitant spironolactone treatment (0, 100, 200, and 400 mg/day)
- Secondary Outcome Measures
Name Time Method Determine whether spironolactone alters subjective and cognitive effects of acute alcohol administration 12 hours after oral alcohol administration Subjective response to alcohol (e.g., sedation, stimulation, mood) and cognitive performance (e.g., psychomotor function, attention) under alcohol administration, during concomitant spironolactone treatment (0, 100, 200, and 400 mg/day)
Determine safety, tolerability, and potential drug-alcohol interaction by administering spironolactone, combined with alcohol, in individuals with AUD 12 hours after oral alcohol administration Number and intensity of adverse events (AEs) experienced under different spironolactone doses (0, 100, 200, 400 mg/day)
Describe steady-state PK of spironolactone metabolites in individuals with AUD, before and after alcohol administration Before and after oral administration of alcohol. PK characteristics (e.g., total concentration, peak concentration, elimination half-life) of spironolactone metabolites; canrenone, TMS, HTMS, before (day 5) and after (day 6) alcohol administration.
Trial Locations
- Locations (1)
National Institute on Drug Abuse
🇺🇸Baltimore, Maryland, United States