Alcohol DependencePhase 2NCT00929344

Duloxetine Versus Pregabalin for Alcohol Dependence

A Phase 2 study testing Pregabalin, Duloxetine and Standardized behavioral therapy in people with Alcohol Dependence, run by The Scripps Research Institute at 1 site 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

A 12-week, double-blind, placebo-controlled parallel group study will be conducted with 150 outpatients with alcohol dependence, with random assignment to pregabalin 300 mg/d, duloxetine 40 mg/d, or placebo in conjunction with manual-guided behavioral counseling and follow-up visits 1 week and 3 months post-treatment. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Alcohol Dependence
What is being tested?: Pregabalin, Duloxetine and Standardized behavioral therapy
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: Jul 2009to Oct 2014
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

Males or females 18 years of age
Meets DSM-IV criteria for current alcohol dependence and drinking an average of ≥21 drinks weekly for males, ≥14 females,
Seeking research-based outpatient treatment for alcohol problems
Willing to attend 12 weekly study visits and 2 follow-up visits
Have normal bilirubin, and ALT, AST, and GGT values no more than 3x the ULN, and no evidence of hepatic insufficiency

Who cannot join

Active suicidal ideation
Medical disorders that will increase potential risk or interfere with study participation
Sexually active female subjects with childbearing potential who are pregnant, nursing or refuse to use a reliable method of birth control
Males who refuse to use a reliable method of birth control
Meets DSM-IV criteria for any other current major AXIS I disorder other than alcohol or nicotine dependence.
Inability to understand and/or comply with the provisions of the protocol and consent form

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Treatment with an antidepressant medication during the two weeks, or fluoxetine during the month, prior to randomization
Ongoing treatment with disulfiram (Antabuse), naltrexone (ReVia), acamprosate (Campral) or other medications that may affect study outcomes, e.g., anticonvulsants or other drugs that act on serotonin in the brain
Ongoing treatment with drugs that may increase potential risk (Actos),

Trial locations and contacts

1 site in 1 country.

United States1 site

The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research
La Jolla, California, 92037

Other trials in United States

About this study

Conditions: Alcohol Dependence
Being tested: Pregabalin, Duloxetine, Standardized behavioral therapy, Placebo
Keywords: Alcohol, Alcohol treatment, Alcoholism, Alcohol Abuse, 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.

PregabalinDrug
Also called Lyrica
Two 150 mg capsules, 150 mg/am and 150 mg/pm (Total dose, 300mg/d), 12 week duration. Dose may be increased up to 600 mg/d or reduced to 150 mg/d based on subject response and tolerability.
DuloxetineDrug
Also called Cymbalta
40 mg capsule, Once daily/am, 12 week duration, placebo capsule administered pm. Dose may be increased up to 60 mg/d or reduced to 20 mg/d based on subject response and tolerability.
Standardized behavioral therapyBehavioural
Also called Manually-guided therapy
Standardized behavioral therapy 1 time per week for 12 week duration.
Standardized behavioral therapyBehavioural
Also called Manually-guided therapy
Standardized behavioral therapy 1 time per week for 12 week duration.
PlaceboDrug
Matched placebo capsule administered 1 capsule am and 1 capsule pm for 12 week duration.
Standardized behavioral therapyBehavioural
Also called Manually-guided therapy
Standardized behavioral therapy 1 time per week for 12 week duration.

Study groups in NCT00929344
Study group	Role	What they receive
Duloxetine	Experimental	Not described Receives: Drug: Duloxetine; Behavioral: Standardized behavioral therapy
Pregabalin	Experimental	Not described Receives: Drug: Pregabalin; Behavioral: Standardized behavioral therapy
Placebo	Placebo comparator	Not described Receives: Drug: Placebo; Behavioral: Standardized behavioral therapy

What is being measured

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

Change From Baseline in Drinking Quantity and Frequency Using Drinks Per Week at Week 12
Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. Change = (Week 12 - Baseline). More negative values indicate less use of alcohol.
Measured: Baseline and Week 12
Change From Baseline in Drinking Quantity and Frequency Using Drinking Days Per Week at Week 12
Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. A drinking day is a day where any alcohol is consumed. Change = (Week 12 - Baseline). More negative values indicate less use of alcohol.
Measured: Baseline and Week 12
Change From Baseline in Drinking Quantity and Frequency Using Drinks Per Drinking Day at Week 12
Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. A drinking day is a day where any alcohol is consumed. Change = (Week 12 - Baseline). More negative values indicate less use of alcohol.
Measured: Baseline and Week 12

Timeline

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

Jul 2009Oct 2014

First posted29 Jun 2009 (estimated)
Study startJul 2009
Primary completionOct 2014
Study completionOct 2014

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 Alcohol DependenceStudies 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00929344
Sponsor's protocol ID: AA014028
Other IDs: R37AA014028, MERIT
Status last verified: Mar 2017
First submitted: 26 Jun 2009
Last updated: 4 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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 Alcohol Dependence trials

Study at a glance

From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Duloxetine Versus Pregabalin for Alcohol Dependence
ClinicalTrials.gov ID: NCT00929344
Acronym / sponsor ID: AA014028
Conditions: Alcohol Dependence
Keywords: Alcohol, Alcohol treatment, Alcoholism, Alcohol Abuse, 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: Jul 2009
Primary completion: Oct 2014 (actual)
Study completion: Oct 2014 (actual)
First posted: 29 Jun 2009 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Duloxetine	Experimental	Drug: Duloxetine, Behavioral: Standardized behavioral therapy
Pregabalin	Experimental	Drug: Pregabalin, Behavioral: Standardized behavioral therapy
Placebo	Placebo comparator	Drug: Placebo, Behavioral: Standardized behavioral therapy

Who may qualify

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

Key inclusion criteria (5 listed)

Males or females 18 years of age
Meets DSM-IV criteria for current alcohol dependence and drinking an average of ≥21 drinks weekly for males, ≥14 females,
Seeking research-based outpatient treatment for alcohol problems
Willing to attend 12 weekly study visits and 2 follow-up visits
Have normal bilirubin, and ALT, AST, and GGT values no more than 3x the ULN, and no evidence of hepatic insufficiency

Key exclusion criteria (9 listed)

Active suicidal ideation
Medical disorders that will increase potential risk or interfere with study participation
Sexually active female subjects with childbearing potential who are pregnant, nursing or refuse to use a reliable method of birth control
Males who refuse to use a reliable method of birth control
Meets DSM-IV criteria for any other current major AXIS I disorder other than alcohol or nicotine dependence.

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
PregabalinAlso: LyricaTwo 150 mg capsules, 150 mg/am and 150 mg/pm (Total dose, 300mg/d), 12 week duration. Dose may be increased up to 600 mg/d or reduced to 150 mg/d based on subject response and tolerability.	Drug	Pregabalin
DuloxetineAlso: Cymbalta40 mg capsule, Once daily/am, 12 week duration, placebo capsule administered pm. Dose may be increased up to 60 mg/d or reduced to 20 mg/d based on subject response and tolerability.	Drug	Duloxetine
Standardized behavioral therapyAlso: Manually-guided therapyStandardized behavioral therapy 1 time per week for 12 week duration.	Behavioural	Duloxetine
Standardized behavioral therapyAlso: Manually-guided therapyStandardized behavioral therapy 1 time per week for 12 week duration.	Behavioural	Pregabalin
PlaceboMatched placebo capsule administered 1 capsule am and 1 capsule pm for 12 week duration.	Drug	Placebo
Standardized behavioral therapyAlso: Manually-guided therapyStandardized behavioral therapy 1 time per week for 12 week duration.	Behavioural	Placebo

Primary outcome

Change From Baseline in Drinking Quantity and Frequency Using Drinks Per Week at Week 12
Time frame: Baseline and Week 12
Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. Change = (Week 12 - Baseline). More negative values indicate less use of alcohol.
Change From Baseline in Drinking Quantity and Frequency Using Drinking Days Per Week at Week 12
Time frame: Baseline and Week 12
Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. A drinking day is a day where any alcohol is consumed. Change = (Week 12 - Baseline). More negative values indicate less use of alcohol.
Change From Baseline in Drinking Quantity and Frequency Using Drinks Per Drinking Day at Week 12
Time frame: Baseline and Week 12
Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. A drinking day is a day where any alcohol is consumed. Change = (Week 12 - Baseline). More negative values indicate less use of alcohol.

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
Duloxetine	50	28
Pregabalin	50	37
Placebo	50	29

Primary outcome: Change From Baseline in Drinking Quantity and Frequency Using Drinks Per Week at Week 12

Time frame: Baseline and Week 12. Mean (Standard Deviation). Unit: drinks/week

Measure	Duloxetine n = 28	Pregabalin n = 37	Placebo n = 29
Drinks/week Baseline	42.07 (17.94)	56.67 (50.93)	41.20 (27.39)
Drinks/week Week 12	9.16 (11.90)	7.59 (15.73)	8.06 (11.22)
Drinks/week Change	-32.91 (20.38)	-49.08 (44.91)	-33.15 (23.32)

Primary outcome: Change From Baseline in Drinking Quantity and Frequency Using Drinking Days Per Week at Week 12

Time frame: Baseline and Week 12. Mean (Standard Deviation). Unit: drinking days/week

Measure	Duloxetine n = 28	Pregabalin n = 37	Placebo n = 29
Drinking Days/Week Baseline	5.11 (1.29)	4.54 (1.64)	4.87 (1.60)
Drinking Days/Week Week 12	2.17 (2.59)	1.14 (1.90)	1.85 (2.20)
Drinking Days/Week Change	-2.94 (2.68)	-3.40 (2.03)	-3.01 (2.20)

Primary outcome: Change From Baseline in Drinking Quantity and Frequency Using Drinks Per Drinking Day at Week 12

Time frame: Baseline and Week 12. Mean (Standard Deviation). Unit: drinks/drinking day

Measure	Duloxetine n = 28	Pregabalin n = 37	Placebo n = 29
Drinks/Drinking Day Baseline	8.16 (2.69)	12.98 (11.14)	8.91 (5.41)
Drinks/Drinking Day Week 12	2.21 (2.65)	2.31 (3.81)	2.90 (3.62)
Drinks/Drinking Day Change	-5.94 (3.54)	-10.67 (11.34)	-6.01 (4.84)

Adverse events

Time frame: Adverse event data was collected weekly at all 14 study visits during the double blind portion of the study, an average duration of 12 weeks. Adverse event data was also collected during two additional follow up visits, at Weeks 13 and 24.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Duloxetine	2 of 50 (4%)	43 of 50 (86%)	Not reported
Pregabalin	0 of 50 (0%)	35 of 50 (70%)	Not reported
Placebo	4 of 50 (8%)	33 of 50 (66%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Study InformationLink provided by the sponsor.

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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.

Barbara J Mason, Ph.D. principal investigator

The Scripps Research Institute

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 Pregabalin, Duloxetine and Standardized behavioral therapy in people with 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 5 inclusion and 9 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 4 May 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 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?

Change From Baseline in Drinking Quantity and Frequency Using Drinks Per Week at Week 12 (time frame: Baseline and Week 12). The study lists 3 primary outcomes in all. 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 NCT00929344.

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 4 May 2017.