National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Who can join
Adults 21 to 65, any sex, with Alcoholism or Alcohol Dependence. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Total Amount of Alcohol Consumed During the Alcohol Self Administration (ASA) SessionPrimary· 2 hours
Amount of alcohol was measured as the number of mini-drinks each participant decided to drink (0-8 mini-drinks). The alcohol content of each mini-drink was calculated based on the participants' total body water, and was designed to raise the blood alcohol concentration by 0.015 g/dL.
Group
Value
95% CI
Baclofen
4.11
± 0.66
Placebo
4.5
± 0.72
Adverse events — posted to ClinicalTrials.gov
Time frame: 15 days.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Background:
\- Baclofen is a drug used to control muscle stiffness in people with neurological diseases. Some studies suggest that baclofen may reduce alcohol craving and use. It helps to reduce anxiety in alcoholics, which in turn can help to reduce cravings. Researchers want to see if baclofen can be a safe and effective treatment for alcoholics who have high anxiety levels.
Objectives:
\- To see if baclofen is safe and helpful for people who have alcoholism and high anxiety levels.
Eligibility:
* Individuals between 21 and 65 years of age who have been diagnosed with alcoholism and anxiety issues.
* Participants must not be taking anti-anxiety medication.
Design:
* Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Tests of alcohol dependency and anxiety levels will also be given.
* Participants will be divided into two groups. One group will take baclofen. The other group will have a placebo.
* About 1 week after the screening visit, participants will have a study visit. They will answer questions about their behavior and mood. They will then start to take either baclofen or a placebo. Participants will take the study drug three times a day, every day.
* After 1 week on the study drug, participants will have an overnight stay at the National Institutes of Health. They will have blood tests and answer questions about mood and behavior. They will also have tests that involve choosing to drink alcohol and answering more questions about cravings.
* Participants will stop taking their study drug over a 3-day period.
* A final follow-up visit will be required 1 week after the overnight study visit. Participants will receive information about other alcohol abuse treatment programs.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06175507 — Efficacy of Baclofen Vs Naltrexon in Achieving & Maintaining Abstinence in Alcohol Dependence.
· NA
· unknown
NCT05877807 — Effect of Baclofen to Prevent Post-Traumatic Stress Disorder
· completed
NCT05975684 — Baclofen for Children With Rumination Syndrome
· Phase 3
· completed
NCT05418049 — Evaluating the Neurophysiologic and Clinical Effects of Single Dose Drug Challenge
· Phase 2
· active not recruiting
NCT05161351 — Evaluating the Safety of Acute Baclofen in Methadone-maintained Individuals With Opiate Dependence.
· Phase 4
· completed
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Other National Institute on Alcohol Abuse and Alcoholism (NIAAA) trials
Trials by the same sponsor.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Last refreshed: 18 September 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01751386.