AlcoholismPhase 2NCT01751386
Baclofen for Treating Anxiety and Alcoholism
A Phase 2 study testing Baclofen in people with Alcoholism and Alcohol Dependence, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcoholism, Alcohol Dependence, Alcohol Drinking Related Problems
- What is being tested?
- Baclofen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2012to 17 Aug 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be male or female between 21 and 65 years old (inclusive).
- Participants must meet criteria for current DSM-IV-TR diagnosis of alcohol dependence, supported by the Structured Clinical Interview for DSM-IV-TR Axis I Disorders (SCID).
- Participants must have a Trait STAI > 39.
- Participants must be in good health as confirmed by medical history, physical examination, ECG, blood/urine lab tests.
- Females must be postmenopausal for at least one year, surgically sterile, or practicing an effective method of birth control before entry and throughout the study; have a negative urine pregnancy test at each visit. Reliable methods of birth control include oral contraceptives or Norplant ; barrier methods such as diaphragms with contraceptive jelly, cervical caps with contraceptive jelly, condoms with contraceptive foam, or intrauterine devices; a partner with a vasectomy; or abstinence from intercourse.
Who cannot join
- Individuals expressing interest in treatment for alcoholism and/or anxiety.
- Pregnancy or breast feeding women or not using an adequate form of birth control
- Unable to provide a negative urine drug screen.
- Individuals diagnosed with a current substance dependence diagnosis, other than alcohol or nicotine.
- Meet DSM-IV Axis I criteria for a lifetime diagnosis of schizophrenia, bipolar disorder, or other psychoses.
- An active illness within the past 6 months of Visit 1 that meet the DSM-IV criteria for a diagnosis of Major Depressive Disorder (MDD). Subjects with a history of attempted suicide will be excluded.
Show all 12Show fewer
- Clinically significant medical abnormalities (i.e., unstable hypertension, clinically significant ECG abnormalities, Creatinine greater than or equal to 2 mg/dL). Although baclofen has demonstrated a safe profile when administered to alcoholic individuals with liver cirrhosis, including those with Hepatitis C, this study employs the oral administration of alcohol. Therefore, individuals with clinically significant liver problems will be excluded, i.e. liver cirrhosis, AST or ALT > 5 times the upper normal limit (UNL), and individuals with Hepatitis B and C.
- Current use of psychotropic medications that cannot be discontinued and that may have an effect on alcohol consumption (thus confounding the results of the study) or that may interact with baclofen. Specifically, contraindicated medications will include: naltrexone, acamprosate, alcohol dehydrogenase inhibitors, topiramate, gabapentin, ondansetron, benzodiazepines, beta-blockers, H2-blockers, and alpha-1 blockers.
- Medical contraindications for use of baclofen.
- A history of adverse reaction or hypersensitivity to baclofen.
- Participants who have significant alcohol withdrawal symptoms, defined as a CIWA-Ar > 8.
- History of epilepsy or alcohol-related seizures.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: A Double-Blind, Placebo-Controlled, Randomized Human Laboratory Pilot Study of Baclofen in Anxious Alcoholics
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.
Read more
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.
Read the detailed description
Objective:
The selective GABAB receptor agonist baclofen has been identified as a possible medication able to reduce alcohol craving and intake in alcohol dependent individuals. In keeping with several preclinical studies, most of the clinical studies have demonstrated baclofen s effects in reducing alcohol craving and intake and promoting alcohol abstinence. However, one trial with alcoholics with a low severity of dependence found a robust treatment effect, but no differences between baclofen and placebo. The inconsistency of baclofen s effects on alcohol drinking among previous treatment trials suggests that different AD individuals may respond differently to baclofen. Baclofen has been demonstrated to consistently reduce anxiety in alcoholic patients, and analyses of positive vs. null findings with baclofen suggest that alcoholic patients with higher levels of anxiety at baseline may represent a sub-population particularly responsive to baclofen treatment. Therefore, this study will systematically test, for the first time, the specific role of baclofen on alcohol-related outcomes in alcoholic individuals with high anxiety levels. Furthermore, the biobehavioral mechanisms by which baclofen reduces drinking are not well characterized. A human laboratory pilot study conducted at Brown University with non-treatment seeking alcohol-dependent individuals suggests that baclofen reduces alcohol consumption both in the naturalistic environment as well as in a well-controlled lab setting (using an alcohol self-administration [ASA] paradigm) and that this could be mediated by baclofen s ability to alter alcohol-related biphasic effects. An exploratory analysis also revealed that specific genetic polymorphisms might moderate baclofen s effects, i.e. DRD4 and 5HTTLPR polymorphisms, although the sample of that pilot study was very small to allow one to draft definitive conclusions. The present project proposes investigating baclofen using a design similar to that used in the previous pilot study (thus, an already validated paradigm), thus representing not only the first study testing baclofen in alcoholic individuals with high anxiety levels, but also the first study investigating baclofen s biobehavioral mechanisms in such a population for which baclofen may hypothetically show a very robust effect.
Study population:
Non-treatment seeking alcohol-dependent males and females with high anxiety levels.
Design:
The experimental design is a between-subject randomized double-blind controlled study. The medication conditions baclofen t.i.d. or placebo represent the between subjects factor. Each participant will be randomly assigned to one of the two medication conditions and will receive eight days of the medication, followed by an alcohol laboratory session on Day 8. The alcohol laboratory session will be conducted in a bar-like room in the NIAAA Outpatient Clinic of the NIH CRC. The study will be conducted in consecutive phases which will appear contiguous to volunteers: (1) a one-week screening period; (2) an 8-day period (+ 1-5 days if needed to permit some participants flexibility in scheduling the laboratory session) during which participants will take the study medication; (3) an alcohol laboratory session, including a cue reactivity (CR) test and an alcohol self-administration (ASA) procedure on Day 8 (last day at the target dose); (4) a 3-day period during which participants will undergo a dose reduction of the study medication; (5) a 1-week follow-up (including the tapering phase).
Outcome measures:
Alcohol drinking during the ASA will be measured as the primary outcome. Secondary objectives include baclofen s effects on alcohol cue-induced responses (urge to drink, attention to cues, blood pressure, heart rate, saliva), on the subjective effects of alcohol and on anxiety levels. We will also explore the role of possible moderators of baclofen s effects, namely family history of alcoholism, early vs. later onset of alcoholism, pre-treatment anxiety levels and genetic moderators (DRD4, 5-HTTPRL). This study does not offer direct benefit to participants but is likely to yield generalizable knowledge about the possible role of baclofen in treating alcoholic individuals with high anxiety levels. This will markedly facilitate the identification of a novel pharmacotherapy, thus facilitating the development of novel alcoholism treatments.
- Conditions
- Alcoholism, Alcohol Dependence, Alcohol Drinking Related Problems, Alcohol Drinking, Anxiety Disorder
- Being tested
- Baclofen, Placebo
- Keywords
- Addiction, Cue-Induced Craving, Craving, Anxiety, Alcohol Consumption
- Medical subject headings
- Alcoholism, Alcohol Drinking, Anxiety Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaclofenDrug
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Baclofen | Experimental | Baclofen 10 mg t.i.d. Receives: Drug: Baclofen |
| Placebo | Placebo comparator | Placebo t.i.d. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Amount of Alcohol Consumed During the Alcohol Self Administration (ASA) Session
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.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2012 (estimated)
- Study start3 Dec 2012
- Primary completion17 Aug 2016
- Study completion17 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for AlcoholismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Lorenzo Leggio, M.D., Principal investigator, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01751386
- Sponsor's protocol ID
- 130040
- Other IDs
- 13-AA-0040
- Status last verified
- 17 Jul 2017
- First submitted
- 13 Dec 2012
- Last updated
- 18 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The NIH Biomedical Translational Research Information System
Publications
Addolorato G, Abenavoli L, Leggio L, Gasbarrini G. How many cravings? Pharmacological aspects of craving treatment in alcohol addiction: a review. Neuropsychobiology. 2005;51(2):59-66. doi: 10.1159/000084161. Epub 2005 Feb 28.
PubMed 15741745Addolorato G, Caputo F, Capristo E, Domenicali M, Bernardi M, Janiri L, Agabio R, Colombo G, Gessa GL, Gasbarrini G. Baclofen efficacy in reducing alcohol craving and intake: a preliminary double-blind randomized controlled study. Alcohol Alcohol. 2002 Sep-Oct;37(5):504-8. doi: 10.1093/alcalc/37.5.504.
PubMed 12217947Addolorato G, Caputo F, Capristo E, Janiri L, Bernardi M, Agabio R, Colombo G, Gessa GL, Gasbarrini G. Rapid suppression of alcohol withdrawal syndrome by baclofen. Am J Med. 2002 Feb 15;112(3):226-9. doi: 10.1016/s0002-9343(01)01088-9. No abstract available.
PubMed 11893350Leggio L, Zywiak WH, Edwards SM, Tidey JW, Swift RM, Kenna GA. A preliminary double-blind, placebo-controlled randomized study of baclofen effects in alcoholic smokers. Psychopharmacology (Berl). 2015 Jan;232(1):233-43. doi: 10.1007/s00213-014-3652-9. Epub 2014 Jun 29.
PubMed 24973894Leggio L, Zywiak WH, McGeary JE, Edwards S, Fricchione SR, Shoaff JR, Addolorato G, Swift RM, Kenna GA. A human laboratory pilot study with baclofen in alcoholic individuals. Pharmacol Biochem Behav. 2013 Feb;103(4):784-91. doi: 10.1016/j.pbb.2012.11.013. Epub 2012 Dec 19.
PubMed 23262301Leggio L, Ferrulli A, Zambon A, Caputo F, Kenna GA, Swift RM, Addolorato G. Baclofen promotes alcohol abstinence in alcohol dependent cirrhotic patients with hepatitis C virus (HCV) infection. Addict Behav. 2012 Apr;37(4):561-4. doi: 10.1016/j.addbeh.2011.12.010. Epub 2011 Dec 27.
PubMed 22244707Farokhnia M, Schwandt ML, Lee MR, Bollinger JW, Farinelli LA, Amodio JP, Sewell L, Lionetti TA, Spero DE, Leggio L. Biobehavioral effects of baclofen in anxious alcohol-dependent individuals: a randomized, double-blind, placebo-controlled, laboratory study. Transl Psychiatry. 2017 Apr 25;7(4):e1108. doi: 10.1038/tp.2017.71.
PubMed 28440812Richardson RS, Farokhnia M, Vendruscolo LF, Leggio L. Plasma concentrations of the inflammatory adipokine lipocalin-2 are not affected by chronic alcohol exposure in rats or acute alcohol administration in people with alcohol use disorder. Am J Drug Alcohol Abuse. 2025;51(6):730-740. doi: 10.1080/00952990.2025.2582563. Epub 2025 Dec 2.
PubMed 41329966
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Randomized Human Laboratory Pilot Study of Baclofen in Anxious Alcoholics
- ClinicalTrials.gov ID
- NCT01751386
- Acronym / sponsor ID
- 130040
- Conditions
- Alcoholism, Alcohol Dependence, Alcohol Drinking Related Problems, Alcohol Drinking, Anxiety Disorder
- Keywords
- Addiction, Cue-Induced Craving, Craving, Anxiety, Alcohol Consumption
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)US National Institutes of Health
- Study start
- 3 Dec 2012
- Primary completion
- 17 Aug 2016 (actual)
- Study completion
- 17 Aug 2016 (actual)
- First posted
- 18 Dec 2012 (estimated)
- Results
- Posted 16 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objective:
The selective GABAB receptor agonist baclofen has been identified as a possible medication able to reduce alcohol craving and intake in alcohol dependent individuals. In keeping with several preclinical studies, most of the clinical studies have demonstrated baclofen s effects in reducing alcohol craving and intake and promoting alcohol abstinence. However, one trial with alcoholics with a low severity of dependence found a robust treatment effect, but no differences between baclofen and placebo. The inconsistency of baclofen s effects on alcohol drinking among previous treatment trials suggests that different AD individuals may respond differently to baclofen. Baclofen has been demonstrated to consistently reduce anxiety in alcoholic patients, and analyses of positive vs. null findings with baclofen suggest that alcoholic patients with higher levels of anxiety at baseline may represent a sub-population particularly responsive to baclofen treatment. Therefore, this study will systematically test, for the first time, the specific role of baclofen on alcohol-related outcomes in alcoholic individuals with high anxiety levels. Furthermore, the biobehavioral mechanisms by which baclofen reduces drinking are not well characterized. A human laboratory pilot study conducted at Brown University with non-treatment seeking alcohol-dependent individuals suggests that baclofen reduces alcohol consumption both in the naturalistic environment as well as in a well-controlled lab setting (using an alcohol self-administration [ASA] paradigm) and that this could be mediated by baclofen s ability to alter alcohol-related biphasic effects. An exploratory analysis also revealed that specific genetic polymorphisms might moderate baclofen s effects, i.e. DRD4 and 5HTTLPR polymorphisms, although the sample of that pilot study was very small to allow one to draft definitive conclusions. The present project proposes investigating baclofen using a design similar to that used in the previous pilot study (thus, an already validated paradigm), thus representing not only the first study testing baclofen in alcoholic individuals with high anxiety levels, but also the first study investigating baclofen s biobehavioral mechanisms in such a population for which baclofen may hypothetically show a very robust effect.
Study population:
Non-treatment seeking alcohol-dependent males and females with high anxiety levels.
Design:
The experimental design is a between-subject randomized double-blind controlled study. The medication conditions baclofen t.i.d. or placebo represent the between subjects factor. Each participant will be randomly assigned to one of the two medication conditions and will receive eight days of the medication, followed by an alcohol laboratory session on Day 8. The alcohol laboratory session will be conducted in a bar-like room in the NIAAA Outpatient Clinic of the NIH CRC. The study will be conducted in consecutive phases which will appear contiguous to volunteers: (1) a one-week screening period; (2) an 8-day period (+ 1-5 days if needed to permit some participants flexibility in scheduling the laboratory session) during which participants will take the study medication; (3) an alcohol laboratory session, including a cue reactivity (CR) test and an alcohol self-administration (ASA) procedure on Day 8 (last day at the target dose); (4) a 3-day period during which participants will undergo a dose reduction of the study medication; (5) a 1-week follow-up (including the tapering phase).
Outcome measures:
Alcohol drinking during the ASA will be measured as the primary outcome. Secondary objectives include baclofen s effects on alcohol cue-induced responses (urge to drink, attention to cues, blood pressure, heart rate, saliva), on the subjective effects of alcohol and on anxiety levels. We will also explore the role of possible moderators of baclofen s effects, namely family history of alcoholism, early vs. later onset of alcoholism, pre-treatment anxiety levels and genetic moderators (DRD4, 5-HTTPRL). This study does not offer direct benefit to participants but is likely to yield generalizable knowledge about the possible role of baclofen in treating alcoholic individuals with high anxiety levels. This will markedly facilitate the identification of a novel pharmacotherapy, thus facilitating the development of novel alcoholism treatments.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baclofen | Experimental | Drug: BaclofenBaclofen 10 mg t.i.d. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo t.i.d. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must be male or female between 21 and 65 years old (inclusive).
- Participants must meet criteria for current DSM-IV-TR diagnosis of alcohol dependence, supported by the Structured Clinical Interview for DSM-IV-TR Axis I Disorders (SCID).
- Participants must have a Trait STAI > 39.
- Participants must be in good health as confirmed by medical history, physical examination, ECG, blood/urine lab tests.
- Females must be postmenopausal for at least one year, surgically sterile, or practicing an effective method of birth control before entry and throughout the study; have a negative urine pregnancy test at each visit. Reliable methods of birth control include oral contraceptives or Norplant ; barrier methods such as diaphragms with contraceptive jelly, cervical caps with contraceptive jelly, condoms with contraceptive foam, or intrauterine devices; a partner with a vasectomy; or abstinence from intercourse.
Key exclusion criteria (12 listed)
- Individuals expressing interest in treatment for alcoholism and/or anxiety.
- Pregnancy or breast feeding women or not using an adequate form of birth control
- Unable to provide a negative urine drug screen.
- Individuals diagnosed with a current substance dependence diagnosis, other than alcohol or nicotine.
- Meet DSM-IV Axis I criteria for a lifetime diagnosis of schizophrenia, bipolar disorder, or other psychoses.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baclofen | Drug | Baclofen |
| Placebo | Other | Placebo |
Primary outcome
Total Amount of Alcohol Consumed During the Alcohol Self Administration (ASA) Session
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15741745Addolorato G, Abenavoli L, Leggio L, Gasbarrini G. How many cravings? Pharmacological aspects of craving treatment in alcohol addiction: a review. Neuropsychobiology. 2005;51(2):59-66. doi: 10.1159/000084161. Epub 2005 Feb 28.
- Background: PubMed 12217947Addolorato G, Caputo F, Capristo E, Domenicali M, Bernardi M, Janiri L, Agabio R, Colombo G, Gessa GL, Gasbarrini G. Baclofen efficacy in reducing alcohol craving and intake: a preliminary double-blind randomized controlled study. Alcohol Alcohol. 2002 Sep-Oct;37(5):504-8. doi: 10.1093/alcalc/37.5.504.
- Background: PubMed 11893350Addolorato G, Caputo F, Capristo E, Janiri L, Bernardi M, Agabio R, Colombo G, Gessa GL, Gasbarrini G. Rapid suppression of alcohol withdrawal syndrome by baclofen. Am J Med. 2002 Feb 15;112(3):226-9. doi: 10.1016/s0002-9343(01)01088-9. No abstract available.
- Background: PubMed 24973894Leggio L, Zywiak WH, Edwards SM, Tidey JW, Swift RM, Kenna GA. A preliminary double-blind, placebo-controlled randomized study of baclofen effects in alcoholic smokers. Psychopharmacology (Berl). 2015 Jan;232(1):233-43. doi: 10.1007/s00213-014-3652-9. Epub 2014 Jun 29.
- Background: PubMed 23262301Leggio L, Zywiak WH, McGeary JE, Edwards S, Fricchione SR, Shoaff JR, Addolorato G, Swift RM, Kenna GA. A human laboratory pilot study with baclofen in alcoholic individuals. Pharmacol Biochem Behav. 2013 Feb;103(4):784-91. doi: 10.1016/j.pbb.2012.11.013. Epub 2012 Dec 19.
- Background: PubMed 22244707Leggio L, Ferrulli A, Zambon A, Caputo F, Kenna GA, Swift RM, Addolorato G. Baclofen promotes alcohol abstinence in alcohol dependent cirrhotic patients with hepatitis C virus (HCV) infection. Addict Behav. 2012 Apr;37(4):561-4. doi: 10.1016/j.addbeh.2011.12.010. Epub 2011 Dec 27.
- Results publication: PubMed 28440812Farokhnia M, Schwandt ML, Lee MR, Bollinger JW, Farinelli LA, Amodio JP, Sewell L, Lionetti TA, Spero DE, Leggio L. Biobehavioral effects of baclofen in anxious alcohol-dependent individuals: a randomized, double-blind, placebo-controlled, laboratory study. Transl Psychiatry. 2017 Apr 25;7(4):e1108. doi: 10.1038/tp.2017.71.
- Derived from this study: PubMed 41329966Richardson RS, Farokhnia M, Vendruscolo LF, Leggio L. Plasma concentrations of the inflammatory adipokine lipocalin-2 are not affected by chronic alcohol exposure in rats or acute alcohol administration in people with alcohol use disorder. Am J Drug Alcohol Abuse. 2025;51(6):730-740. doi: 10.1080/00952990.2025.2582563. Epub 2025 Dec 2.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The NIH Biomedical Translational Research Information System
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorenzo Leggio, M.D. principal investigator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Baclofen in people with Alcoholism and Alcohol Dependence, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Amount of Alcohol Consumed During the Alcohol Self Administration (ASA) Session (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01751386, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2017.