AlcoholismPhase 2NCT00391716
Gabapentin Treatment of Alcohol Dependence
A Phase 2 study testing Gabapentin 900mg, behavioral counseling and gabapentin 1800mg in people with Alcoholism and Alcohol Dependence, run by The Scripps Research Institute at 1 site in United States.
Trial summary
Gabapentin treatment for alcohol dependence Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcoholism, Alcohol Dependence
- What is being tested?
- Gabapentin 900mg, behavioral counseling and gabapentin 1800mg
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2004to Feb 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women over age 18 with alcohol dependence
Who cannot join
- Currently meets Diagnostic and Statistical Manual 4 Text Revision (DSM-IV-TR) criteria for dependence on illicit substances
- Significant medical disorders that will increase potential risk or interfere with study participation
- Women with childbearing potential who are pregnant, nursing, or refuse to use a reliable method of birth control
- Treatment with an investigational drug in the last month.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Scripps Research Institute
La Jolla, California, 92037
About this study
Gabapentin treatment for alcohol dependence
Read the detailed description
This is a 12-week, double blind, placebo controlled, dose ranging study to evaluate the efficacy of gabapentin in treating outpatients with alcohol dependence. Subjects receive 900mg or 1800mg gabapentin or placebo daily for 12 weeks accompanied by weekly standardized counseling for alcohol-related behavior, with assessments of alcohol consumption, mood, sleep and alcohol-craving performed each week.
- Conditions
- Alcoholism, Alcohol Dependence
- Being tested
- Gabapentin 900mg, behavioral counseling, placebo, gabapentin 1800mg
- Keywords
- Alcohol, Alcohol treatment, Alcoholism, Alcohol Dependence
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gabapentin 900mgDrug
Also called Neurontin
900 mg gabapentin daily for 12 weeks
behavioral counselingBehavioural
Also called alcoholfree.info
The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.
placeboDrug
Also called lactose capsule
lactose capsule compounded to mimic gabapentin capsules
gabapentin 1800mgDrug
Also called Neurontin
1800 mg gabapentin daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| gabapentin 900mg daily | Experimental | 900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks. Receives: Drug: Gabapentin 900mg; Behavioral: behavioral counseling |
| gabapentin 1800mg daily | Experimental | 1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks Receives: Behavioral: behavioral counseling; Drug: gabapentin 1800mg |
| placebo daily | Placebo comparator | placebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks. Receives: Behavioral: behavioral counseling; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drinking
Rate of complete abstinence was defined as the number of participants who drank no alcohol during 12 weeks of treatment, where the denominator is the intent to treat population. Rate of heavy drinking abstinence is defined as no heavy drinking days while on study (4 or more for women, 5 or more for men).
Measured: 12-week
Secondary outcomes (3)
Mood
Beck Depression Inventory II consists of 21 questions assessing depression symptoms answered with scores between 0 and 3, summed for a weekly total score between 0 and 63; higher scores indicate more depression. The cumulative mean total depression scores over the 12 week study are tested by ANOVA for differences in cumulative means between treatment groups.
Measured: 12-week
Sleep
The Pittsburgh Sleep Questionnaire Inventory consists of 9 questions about sleep habits which are answered on a scale of 0-3. Results are sorted into 7 sub scales re-scored 0-3, then sub scales are summed for a weekly total score between 0 and 21, with higher total scores indicating greater sleep impairment. Cumulative mean total sleep scores over the 12 weeks of study are assessed by ANOVA for differences between treatment groups.
Measured: 12-week
Craving
Alcohol Craving Questionnaire has 12 questions about alcohol craving which are each scored 1-7, then summed for a weekly score between 7 and 84, with higher scores indicating greater craving. Cumulative mean total craving scores are tested by ANOVA for differences between treatment groups.
Measured: 12-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2006 (estimated)
- Study startFeb 2004
- Primary completionJul 2009
- Study completionFeb 2010
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 (1)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Scripps Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Barbara J. Mason, The Scripps Research Institute
- Investigators
- Barbara J. Mason, PhD, Principal investigator, The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00391716
- Sponsor's protocol ID
- NIAAAMAS014028
- Other IDs
- R37AA014028
- Status last verified
- Nov 2014
- First submitted
- 20 Oct 2006
- Last updated
- 10 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Mason BJ, Quello S, Goodell V, Shadan F, Kyle M, Begovic A. Gabapentin treatment for alcohol dependence: a randomized clinical trial. JAMA Intern Med. 2014 Jan;174(1):70-7. doi: 10.1001/jamainternmed.2013.11950.
PubMed 24190578
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gabapentin Treatment of Alcohol Dependence
- ClinicalTrials.gov ID
- NCT00391716
- Acronym / sponsor ID
- NIAAAMAS014028
- Conditions
- Alcoholism, Alcohol Dependence
- Keywords
- Alcohol, Alcohol treatment, Alcoholism, Alcohol Dependence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- The Scripps Research InstituteUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Feb 2004
- Primary completion
- Jul 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 24 Oct 2006 (estimated)
- Results
- Posted 10 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Gabapentin treatment for alcohol dependence
Detailed description
This is a 12-week, double blind, placebo controlled, dose ranging study to evaluate the efficacy of gabapentin in treating outpatients with alcohol dependence. Subjects receive 900mg or 1800mg gabapentin or placebo daily for 12 weeks accompanied by weekly standardized counseling for alcohol-related behavior, with assessments of alcohol consumption, mood, sleep and alcohol-craving performed each week.
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 |
|---|---|---|
| gabapentin 900mg daily | Experimental | Drug: Gabapentin 900mg, Behavioral: behavioral counseling900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks. |
| gabapentin 1800mg daily | Experimental | Behavioral: behavioral counseling, Drug: gabapentin 1800mg1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks |
| placebo daily | Placebo comparator | Behavioral: behavioral counseling, Drug: placeboplacebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men and women over age 18 with alcohol dependence
Key exclusion criteria (4 listed)
- Currently meets Diagnostic and Statistical Manual 4 Text Revision (DSM-IV-TR) criteria for dependence on illicit substances
- Significant medical disorders that will increase potential risk or interfere with study participation
- Women with childbearing potential who are pregnant, nursing, or refuse to use a reliable method of birth control
- Treatment with an investigational drug in the last month.
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 |
|---|---|---|
| Gabapentin 900mgAlso: Neurontin900 mg gabapentin daily for 12 weeks | Drug | gabapentin 900mg daily |
| behavioral counselingAlso: alcoholfree.infoThe manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info. | Behavioural | gabapentin 1800mg daily, gabapentin 900mg daily, placebo daily |
| placeboAlso: lactose capsulelactose capsule compounded to mimic gabapentin capsules | Drug | placebo daily |
| gabapentin 1800mgAlso: Neurontin1800 mg gabapentin daily for 12 weeks | Drug | gabapentin 1800mg daily |
Primary outcome
Drinking
Time frame: 12-week
Rate of complete abstinence was defined as the number of participants who drank no alcohol during 12 weeks of treatment, where the denominator is the intent to treat population. Rate of heavy drinking abstinence is defined as no heavy drinking days while on study (4 or more for women, 5 or more for men).
3 secondary outcomes
Mood
Time frame: 12-week
Sleep
Time frame: 12-week
Craving
Time frame: 12-week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24190578Mason BJ, Quello S, Goodell V, Shadan F, Kyle M, Begovic A. Gabapentin treatment for alcohol dependence: a randomized clinical trial. JAMA Intern Med. 2014 Jan;174(1):70-7. doi: 10.1001/jamainternmed.2013.11950.
- Link for JAMA Internal Medicine manuscriptLink provided by the sponsor.
Related trials for Alcoholism
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
RecruitingPhase 2
Study on Thiamine Supplementation to REduce braiN Injury Associated With Chronic Alcohol Use in Outpatients With Alcohol Use Disorder
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.
Barbara J. Mason, PhD principal investigator
The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research
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 Gabapentin 900mg, behavioral counseling and gabapentin 1800mg in people with Alcoholism and Alcohol Dependence, run by The Scripps Research Institute 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 1 inclusion and 4 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 10 Nov 2014. 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 10 Nov 2014). 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?
Drinking (time frame: 12-week). 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 NCT00391716, which also lists 1 linked publication.
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 10 Nov 2014.