AlcoholismPhase 1/2NCT00568087
N-acetylcysteine in Alcohol Dependence
A Phase 1/2 study testing N-acetylcysteine in people with Alcoholism, run by Minneapolis Veterans Affairs Medical Center at 1 site in United States.
Trial summary
The present study is designed to find out if N-acetylcysteine works in reducing alcohol drinking and craving. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcoholism
- What is being tested?
- N-acetylcysteine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Aug 2009
- Phase
- Phase 1/2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 - 65
- alcohol dependence by DSM-IV
- heavy drinking at least 4 times in the past month
- able to provide informed consent
Who cannot join
- current drug abuse or dependence by DSM-IV criteria (except nicotine or cannabis)
- current psychotic disorders, bipolar disorders, or cognitive disorders
- current suicidal or homicidal ideation
- positive illicit drug screen (except cannabis)
- Clinical Institute Withdrawal Assessment for Alcohol, Revised >15
- initiation of individual therapy or counseling in the past 3 months
Show all 10Show fewer
- changes in doses of psychiatric medications in the past 3 months
- clinically unstable cardiac, hepatic, renal, neurologic, or pulmonary disease
- current use of naltrexone, disulfiram or acamprosate
- pregnant or nursing women, or inadequate birth control methods in women of childbearing potential
Trial locations and contacts
1 site in 1 country.
United States1 site
Minneapolis VA Medical Center
Minneapolis, Minnesota, 55417
About this study
The present study is designed to find out if N-acetylcysteine works in reducing alcohol drinking and craving.
Read the detailed description
The 2 groups (placebo and N-acetylcysteine) will be compared in a double-blind, placebo-controlled trial. The total study duration is 9 weeks which includes a 1-week screening period and an 8-week randomized study drug treatment period.
- Conditions
- Alcoholism
- Being tested
- N-acetylcysteine, Placebo
- Keywords
- N-acetylcysteine, Alcoholism, Treatment
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetylcysteineDrug
Patients will take oral N-acetylcysteine 900 mg/day for 1 week, 1800 mg/day for 1 week, 2700 mg/day for 1 week, and then 3600 mg/day.
PlaceboDrug
Patients will take oral placebo (identical matching placebo) during the study period.
| Study group | Role | What they receive |
|---|---|---|
| N-acetylcysteine | Active comparator | Patients will take oral N-acetylcysteine 900 mg/day for 1 week, 1800 mg/day for 1 week, 2700 mg/day for 1 week, and then 3600 mg/day. Receives: Drug: N-acetylcysteine |
| Placebo | Placebo comparator | Patients will take oral placebo (identical matching placebo) during the study period. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol Consumption (Percentage of Heavy Drinking Days)
The percentage of heavy drinking days was primary a priori outcome measure. Heavy drinking was defined as ≥ 5 standard drinks per day for men and ≥ 4 standard drinks for women. One standard drink is any drink containing about 0.6 fluid ounces or 14 grams of pure alcohol. The percentage of heavy drinking days (HDD) was measured at each weekly visit during the 8 weeks--from week 1 (before starting intervention) to week 9 (after completing intervention). At each week, the percentage of HDD was calculated during the period (usually 7 days) since the last previous visit.
Measured: The percentage of heavy drinking days (HDD) was measured at each weekly visit during the 8 weeks.
Secondary outcomes (3)
The Penn Alcohol Craving Scale
Alcohol craving was secondary a priori outcome measure. Alcohol craving was measured at each weekly visit during the 8 weeks--from week 1 (before starting intervention) to week 9 (after completing intervention).
The Penn Alcohol Craving Scale is a self-rated scale designed to assess alcohol craving. The score range of the Penn Alcohol Craving Scale is between 0 and 30, with 30 assigned to the highest (worst) alcohol craving.
Measured: The Penn Alcohol Craving Scale was measured at each weekly visit during the 8 weeks.
The Obsessive Compulsive Drinking Scale
Alcohol craving was secondary a priori outcome measure. Alcohol craving was measured at each weekly visit during the 8 weeks--from week 1 (before starting intervention) to week 9 (after completing intervention).
The Obsessive Compulsive Drinking Scale is a self-rated scale designed to assess alcohol craving. The score range of the Obsessive Compulsive Drinking Scale is between 0 and 56, with 56 assigned to the highest (worst) alcohol craving.
Measured: The Obsessive Compulsive Drinking Scale was measured at each weekly visit during the 8 weeks.
Liver Function Tests
Aspartate aminotransaminase (AST) plasma level
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionAug 2009
- Study completionAug 2009
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.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minneapolis Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Minnesota Veterans Medical Research and Education Foundation
- Responsible party
- Principal investigator, Gihyun Yoon, Minneapolis Veterans Affairs Medical Center
- Investigators
- Gihyun Yoon, MD, Principal investigator, Minneapolis Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00568087
- Sponsor's protocol ID
- Protocol #3852-B
- Status last verified
- Mar 2020
- First submitted
- 4 Dec 2007
- Last updated
- 18 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- N-acetylcysteine in Alcohol Dependence
- ClinicalTrials.gov ID
- NCT00568087
- Acronym / sponsor ID
- Protocol #3852-B
- Conditions
- Alcoholism
- Keywords
- N-acetylcysteine, Alcoholism, Treatment
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Minneapolis Veterans Affairs Medical CenterUS federal agency
- Collaborators
- Minnesota Veterans Medical Research and Education Foundation
- Study start
- Dec 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 5 Dec 2007 (estimated)
- Results
- Posted 1 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study is designed to find out if N-acetylcysteine works in reducing alcohol drinking and craving.
Detailed description
The 2 groups (placebo and N-acetylcysteine) will be compared in a double-blind, placebo-controlled trial. The total study duration is 9 weeks which includes a 1-week screening period and an 8-week randomized study drug treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N-acetylcysteine | Active comparator | Drug: N-acetylcysteinePatients will take oral N-acetylcysteine 900 mg/day for 1 week, 1800 mg/day for 1 week, 2700 mg/day for 1 week, and then 3600 mg/day. |
| Placebo | Placebo comparator | Drug: PlaceboPatients will take oral placebo (identical matching placebo) during the study period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18 - 65
- alcohol dependence by DSM-IV
- heavy drinking at least 4 times in the past month
- able to provide informed consent
Key exclusion criteria (10 listed)
- current drug abuse or dependence by DSM-IV criteria (except nicotine or cannabis)
- current psychotic disorders, bipolar disorders, or cognitive disorders
- current suicidal or homicidal ideation
- positive illicit drug screen (except cannabis)
- Clinical Institute Withdrawal Assessment for Alcohol, Revised >15
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 |
|---|---|---|
| N-acetylcysteinePatients will take oral N-acetylcysteine 900 mg/day for 1 week, 1800 mg/day for 1 week, 2700 mg/day for 1 week, and then 3600 mg/day. | Drug | N-acetylcysteine |
| PlaceboPatients will take oral placebo (identical matching placebo) during the study period. | Drug | Placebo |
Primary outcome
Alcohol Consumption (Percentage of Heavy Drinking Days)
Time frame: The percentage of heavy drinking days (HDD) was measured at each weekly visit during the 8 weeks.
The percentage of heavy drinking days was primary a priori outcome measure. Heavy drinking was defined as ≥ 5 standard drinks per day for men and ≥ 4 standard drinks for women. One standard drink is any drink containing about 0.6 fluid ounces or 14 grams of pure alcohol. The percentage of heavy drinking days (HDD) was measured at each weekly visit during the 8 weeks--from week 1 (before starting intervention) to week 9 (after completing intervention). At each week, the percentage of HDD was calculated during the period (usually 7 days) since the last previous visit.
3 secondary outcomes
The Penn Alcohol Craving Scale
Time frame: The Penn Alcohol Craving Scale was measured at each weekly visit during the 8 weeks.
The Obsessive Compulsive Drinking Scale
Time frame: The Obsessive Compulsive Drinking Scale was measured at each weekly visit during the 8 weeks.
Liver Function Tests
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Alcoholism
Recruiting
Tdcs And cogNitive traininG cOmbined for AUD (TANGO)
Alcohol Use Disorder, Addiction
Not yet recruitingPhase 1/2
Intravenous Acetate as an Adjunctive Treatment for Alcohol Withdrawal in Hospitalized Patients
Alcohol Withdrawal, Alcohol Abstinence
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
RecruitingPhase 2
Phase 2 Study of Apremilast in Women and Men With Alcohol Use Disorder
Alcohol Use Disorder
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
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.
Gihyun Yoon, MD principal investigator
Minneapolis Veterans Affairs Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing N-acetylcysteine in people with Alcoholism, run by Minneapolis Veterans Affairs Medical Center 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 4 inclusion and 10 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 Mar 2020. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 1 Nov 2013). 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?
Alcohol Consumption (Percentage of Heavy Drinking Days) (time frame: The percentage of heavy drinking days (HDD) was measured at each weekly visit during the 8 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2020.