AlcoholismPhase 2NCT01214083

N-acetylcysteine Plus Naltrexone for the Treatment of Alcohol Dependence

A Phase 2 study testing N-acetylcysteine + high-dose naltrexone (150 mg), High-dose naltrexone (150 mg) alone and Low-dose naltrexone (50 mg) alone in people with Alcoholism, run by VA Office of Research and Development at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine whether: (1) the combination of N-acetylcysteine + high-dose naltrexone (150 mg) works better than high-dose naltrexone (150 mg) alone in reducing alcohol drinking; and (2) high-dose naltrexone (150 mg) alone works better than low-dose naltrexone (50 mg) alone in reducing… 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 + high-dose naltrexone (150 mg), High-dose naltrexone (150 mg) alone and Low-dose naltrexone (50 mg) alone
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 111 participants
Where: 2 sitesUnited States
Study dates: 15 Oct 2010to 30 Oct 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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

age 18-65 years
alcohol dependence by DSM-IV criteria
heavy drinking at least 6 times within the past month ('heavy drinking' defined as 5 or more standard drinks per day for men and 4 or more standard drinks for women)
able to provide informed consent
a score of 6 or more on the Penn Alcohol Craving Scale (PACS)
subject agrees not to take over-the-counter analgesics during the study

Who cannot join

current drug abuse or dependence by DSM-IV criteria (except nicotine and marijuana)
current psychotic disorders or bipolar disorders
current suicidal or homicidal ideation
positive illicit drug screen test (except marijuana)
ongoing narcotic use or risks for narcotic use during the study
increased risk for severe alcohol withdrawal by a score of 10 or more on the Clinical Institute Withdrawal Assessment for Alcohol, Revised (CIWA-Ar)

Show all 13Show fewer

clinically significant cardiac, hepatic, renal, neurologic, or pulmonary disease
baseline aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 3 times normal
current use of disulfiram, acamprosate or topiramate
pregnant or nursing, or inadequate birth control methods in women of childbearing potential
alcohol breathalyzer level 0.08 or more at the screening visit
severe alcohol withdrawal (delirium tremens or withdrawal seizures) within the past year
currently requiring inpatient treatment for treating alcohol dependence

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, 06516

Other trials in United States

About this study

Read the detailed description

The 3 groups (N-acetylcysteine plus naltrexone 150 mg, naltrexone 150 mg, and naltrexone 50 mg) will be compared in a 12-week randomized, double-blind clinical trial.

Conditions: Alcoholism
Being tested: N-acetylcysteine + high-dose naltrexone (150 mg), High-dose naltrexone (150 mg) alone, Low-dose naltrexone (50 mg) alone
Keywords: N-acetylcysteine, naltrexone
Medical subject headings: Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

N-acetylcysteine + high-dose naltrexone (150 mg)Drug
All subjects will be evaluated weekly for 12 weeks.
High-dose naltrexone (150 mg) aloneDrug
All subjects will be evaluated weekly for 12 weeks.
Low-dose naltrexone (50 mg) aloneDrug
All subjects will be evaluated weekly for 12 weeks.

Study groups in NCT01214083
Study group	Role	What they receive
Arm 1	Experimental	N-acetylcysteine + high-dose naltrexone (150 mg) Receives: Drug: N-acetylcysteine + high-dose naltrexone (150 mg)
Arm 2	Experimental	High-dose naltrexone (150 mg) alone Receives: Drug: High-dose naltrexone (150 mg) alone
Arm 3	Active comparator	Low-dose naltrexone (50 mg) alone Receives: Drug: Low-dose naltrexone (50 mg) alone

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Heavy Drinking Days
"Percentage of heavy drinking days" was measured by the Time Line Follow Back (TLFB) Method. ('Heavy drinking' was defined as 5 or more standard drinks per day for men and 4 or more standard drinks for women.) The percentage has a total range of 0%-100%. Higher percentages represent a worse outcome (i.e., more heavy drinking).
Measured: week 1 and week 13

Secondary outcomes (8)

Liver Function Tests (AST)
Measured: week 0 and week 13
Penn Alcohol Craving Scale (PACS)
The Penn Alcohol Craving Scale is designed to assess alcohol craving severity. The scale has a total score range of 0-30. Higher values represent a worse outcome (i.e., higher craving).
Measured: week 1 and week 13
Obsessive Compulsive Drinking Scale (OCDS)
The Obsessive Compulsive Drinking Scale is designed to assess obsessive and compulsive aspects of alcoholism. The scale has a total score range of 0-56. Higher values represent a worse outcome (i.e., more alcohol problems).
Measured: week 1 and week 13
Clinical Global Impression (CGI)
The Clinical Global Impression is designed to assess overall severity of illness. The scale has a total score range of 1-7. Higher values represent a worse outcome (i.e., severe illness).
Measured: week 1 and week 13
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
The Quality of Life Enjoyment and Satisfaction Questionnaire is designed to assess a quality of life. The scale has a total score range of 16-80. Higher values represent a better outcome (i.e., better quality of life).
Measured: week 1 and week 13
Percentage of Drinking Days
"Percentage of drinking days" was measured by the Time Line Follow Back (TLFB) Method. The percentage has a total range of 0%-100%. Higher percentages represent a worse outcome (i.e., more drinking days).
Measured: week 1 and week 13
Drinks Per Drinking Days
Measured: week 1 and week 13
Liver Function Tests (ALT)
Measured: week 0 and week 13

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Oct 201030 Oct 2016

First posted4 Oct 2010 (estimated)
Study start15 Oct 2010
Primary completion30 Sep 2015
Study completion30 Oct 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.
Other trials for AlcoholismStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 111 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01214083
Sponsor's protocol ID: CDA-2-014-09F
Status last verified: Mar 2020
First submitted: 30 Sep 2010
Last updated: 8 Apr 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Alcoholism trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: N-acetylcysteine Plus Naltrexone for the Treatment of Alcohol Dependence
ClinicalTrials.gov ID: NCT01214083
Acronym / sponsor ID: CDA-2-014-09F
Conditions: Alcoholism
Keywords: N-acetylcysteine, naltrexone
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 111 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: 15 Oct 2010 (actual)
Primary completion: 30 Sep 2015 (actual)
Study completion: 30 Oct 2016 (actual)
First posted: 4 Oct 2010 (estimated)
Results: Posted 28 Mar 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The 3 groups (N-acetylcysteine plus naltrexone 150 mg, naltrexone 150 mg, and naltrexone 50 mg) will be compared in a 12-week randomized, double-blind clinical trial.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Arm 1	Experimental	Drug: N-acetylcysteine + high-dose naltrexone (150 mg)N-acetylcysteine + high-dose naltrexone (150 mg)
Arm 2	Experimental	Drug: High-dose naltrexone (150 mg) aloneHigh-dose naltrexone (150 mg) alone
Arm 3	Active comparator	Drug: Low-dose naltrexone (50 mg) aloneLow-dose naltrexone (50 mg) alone

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

age 18-65 years
alcohol dependence by DSM-IV criteria
heavy drinking at least 6 times within the past month ('heavy drinking' defined as 5 or more standard drinks per day for men and 4 or more standard drinks for women)
able to provide informed consent
a score of 6 or more on the Penn Alcohol Craving Scale (PACS)

Key exclusion criteria (13 listed)

current drug abuse or dependence by DSM-IV criteria (except nicotine and marijuana)
current psychotic disorders or bipolar disorders
current suicidal or homicidal ideation
positive illicit drug screen test (except marijuana)
ongoing narcotic use or risks for narcotic use during the study

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-acetylcysteine + high-dose naltrexone (150 mg)All subjects will be evaluated weekly for 12 weeks.	Drug	Arm 1
High-dose naltrexone (150 mg) aloneAll subjects will be evaluated weekly for 12 weeks.	Drug	Arm 2
Low-dose naltrexone (50 mg) aloneAll subjects will be evaluated weekly for 12 weeks.	Drug	Arm 3

Primary outcome

Percentage of Heavy Drinking Days
Time frame: week 1 and week 13
"Percentage of heavy drinking days" was measured by the Time Line Follow Back (TLFB) Method. ('Heavy drinking' was defined as 5 or more standard drinks per day for men and 4 or more standard drinks for women.) The percentage has a total range of 0%-100%. Higher percentages represent a worse outcome (i.e., more heavy drinking).

8 secondary outcomes

Liver Function Tests (AST)
Time frame: week 0 and week 13
Penn Alcohol Craving Scale (PACS)
Time frame: week 1 and week 13
Obsessive Compulsive Drinking Scale (OCDS)
Time frame: week 1 and week 13
Clinical Global Impression (CGI)
Time frame: week 1 and week 13
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Time frame: week 1 and week 13
Percentage of Drinking Days
Time frame: week 1 and week 13
Drinks Per Drinking Days
Time frame: week 1 and week 13
Liver Function Tests (ALT)
Time frame: week 0 and week 13

Results and safety

Results posted to the registry on 28 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
N-acetylcysteine + High-dose Naltrexone (150 mg)	31	19
High-dose Naltrexone (150 mg) Alone	33	23
Low-dose Naltrexone (50 mg) Alone	31	21

Primary outcome: Percentage of Heavy Drinking Days

Time frame: week 1 and week 13. Mean (Standard Error). Unit: percentage of heavy drinking days

Measure	N-acetylcysteine + High-dose Naltrexone (150 mg) n = 31	High-dose Naltrexone (150 mg) Alone n = 33	Low-dose Naltrexone (50 mg) Alone n = 31
Percentage of heavy drinking days at week 1	45.0 (4.5)	50.6 (4.3)	44.0 (4.5)
Percentage of heavy drinking days at week 13	5.2 (5.6)	3.4 (5.1)	3.3 (5.3)

8 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
N-acetylcysteine + High-dose Naltrexone (150 mg)	0 of 31 (0%)	14 of 31 (45.2%)	Not reported
High-dose Naltrexone (150 mg) Alone	0 of 33 (0%)	12 of 33 (36.4%)	Not reported
Low-dose Naltrexone (50 mg) Alone	0 of 31 (0%)	9 of 31 (29%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Alcoholism

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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.

Gihyun Yoon, MD principal investigator

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 13 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 8 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. 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 28 Mar 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?

Percentage of Heavy Drinking Days (time frame: week 1 and week 13). 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 NCT01214083.

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 8 Apr 2020.