Nicotine DependencePhase 2NCT00802412

Topiramate to Aid Smoking Cessation in Alcohol Dependent Men

A Phase 2 study testing Topiramate in people with Nicotine Dependence and Alcohol Dependence, run by VA Office of Research and Development 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

The purpose of this study is to determine whether topiramate is effective as an aid to smoking cessation for recovering alcohol dependent men. Read more about this study

Who is it for?: Ages 18 to 70 years, men only
Conditions the study is for: Nicotine Dependence, Alcohol Dependence
What is being tested?: Topiramate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 132 participants
Where: 1 siteUnited States
Study dates: Jan 2009to Jun 2015
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 70 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects will be included if they:
are 18-70 years of age, inclusive;
are male outpatients with a diagnosis of DSM-IV-TR nicotine dependence and alcohol dependence in early full remission (1-36 months abstinence);
are current tobacco smokers who smoke an average of 10 or more cigarettes per day in the two months prior to the screening visit;
are motivated to try to quit smoking and maintain abstinence from alcohol and other illicit drugs;

Who cannot join

Subjects will be excluded if they:
have any clinically significant laboratory evidence of hematologic, hepatic, cardiovascular, renal, pulmonary, or thyroid disease;
have a current significant neurologic, hepatic, renal, gastrointestinal, pulmonary, metabolic, cardiovascular, infectious, or endocrine disease;
have a history of known hypersensitivity to topiramate;
in the investigator's judgment, pose a current suicidal or homicidal risk;
have taken any investigational drug within 30 days of baseline; and
have a current seizure disorder or a history of severe alcohol withdrawal (alcohol withdrawal seizures, hallucinations / illusions, delirium tremens).

Trial locations and contacts

1 site in 1 country.

United States1 site

VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161

Other trials in United States

About this study

Official title: Topiramate to Aid Smoking Cessation in Recovering Alcohol Dependent Men

The purpose of this study is to determine whether topiramate is effective as an aid to smoking cessation for recovering alcohol dependent men.

Read the detailed description

This study is a 12-week, double-blind, placebo-controlled trial to test the efficacy of topiramate versus placebo as an aid to smoking cessation for recovering alcohol dependent men. Another aim of the study is to explore whether or not topiramate reduces relapse to alcohol use in patients with comorbid alcohol and nicotine dependence. All participants will receive a standardized psychosocial intervention in combination with the medication (or placebo). Following completion of the treatment phase of the study, participants will enter a 24-week follow-up period during which the longer-term outcome of the intervention will be assessed.

Conditions: Nicotine Dependence, Alcohol Dependence
Being tested: Topiramate, Placebo
Keywords: tobacco use disorders, alcoholism
Medical subject headings: Tobacco Use Disorder, Alcoholism

What participants receive

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

TopiramateDrug
Also called Topamax
Topiramate will be titrated over 5 weeks to a maximum dosage of 200 mg according to the following schedule: 25mg daily for days 1-7, 50mg daily for days 8-14, 75mg daily for days 15-21, 100mg daily for days 22-28, 150mg daily for days 29-35, 200mg daily for days 36-42. Maximum dosage will be maintained for 6 weeks, followed by a one-week taper-off period (100mg daily for 4 days and 50mg daily for 3 days).
PlaceboDrug
Placebo/study medication will be administered in opaque capsules in an identical fashion to maintain the double-blind study design.

Study groups in NCT00802412
Study group	Role	What they receive
Topiramate	Other	The subjects for the proposed study will be 180 currently smoking, treatment-seeking male veterans with alcohol and nicotine dependence. Ninety subjects will be randomized to the topiramate arm and 90 subjects will be randomized to the placebo group. Receives: Drug: Topiramate
Placebo	Placebo comparator	90 participants, will receive matching placebo Receives: Drug: Placebo

What is being measured

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

4-week Continuous Abstinence From Smoking
This measure indicates the proportion of participants who did or did not smoke any cigarettes during the final 4 weeks of treatment, which represented weeks 8-12 of study participation.
Measured: Weeks 8-12 of treatment.

Secondary outcomes (1)

Percent Relapsing to Any Drinking or Illicit Drug Use
Alcohol or illicit drug use during treatment or follow up.
Measured: 12-week treatment phase, 36-week combined treatment and follow-up

Timeline

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

Jan 2009Jun 2015

First posted4 Dec 2008 (estimated)
Study startJan 2009
Primary completionNov 2014
Study completionJun 2015

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 Nicotine DependenceStudies 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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 132 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00802412
Sponsor's protocol ID: NEUA-003-08S
Status last verified: Dec 2016
First submitted: 3 Dec 2008
Last updated: 31 Jan 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Anthenelli RM, Heffner JL, Wong E, Tibbs J, Russell K, Isgro M, Dinh E, Wehrle C, Worley MJ, Doran N. A Randomized Trial Evaluating Whether Topiramate Aids Smoking Cessation and Prevents Alcohol Relapse in Recovering Alcohol-Dependent Men. Alcohol Clin Exp Res. 2017 Jan;41(1):197-206. doi: 10.1111/acer.13279. Epub 2016 Dec 28.
PubMed 28029173

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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Study at a glance

From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Topiramate to Aid Smoking Cessation in Recovering Alcohol Dependent Men
ClinicalTrials.gov ID: NCT00802412
Acronym / sponsor ID: NEUA-003-08S
Conditions: Nicotine Dependence, Alcohol Dependence
Keywords: tobacco use disorders, alcoholism
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 132 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: Jan 2009
Primary completion: Nov 2014 (actual)
Study completion: Jun 2015 (actual)
First posted: 4 Dec 2008 (estimated)
Results: Posted 31 Jan 2017

Clinical summary

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

The purpose of this study is to determine whether topiramate is effective as an aid to smoking cessation for recovering alcohol dependent men.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Topiramate	Other	Drug: TopiramateThe subjects for the proposed study will be 180 currently smoking, treatment-seeking male veterans with alcohol and nicotine dependence. Ninety subjects will be randomized to the topiramate arm and 90 subjects will be randomized to the placebo group.
Placebo	Placebo comparator	Drug: Placebo90 participants, will receive matching placebo

Who may qualify

Ages: 18 to 70 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

are 18-70 years of age, inclusive;
are male outpatients with a diagnosis of DSM-IV-TR nicotine dependence and alcohol dependence in early full remission (1-36 months abstinence);
are current tobacco smokers who smoke an average of 10 or more cigarettes per day in the two months prior to the screening visit;
are motivated to try to quit smoking and maintain abstinence from alcohol and other illicit drugs;

Key exclusion criteria (7 listed)

have any clinically significant laboratory evidence of hematologic, hepatic, cardiovascular, renal, pulmonary, or thyroid disease;
have a current significant neurologic, hepatic, renal, gastrointestinal, pulmonary, metabolic, cardiovascular, infectious, or endocrine disease;
have a history of known hypersensitivity to topiramate;
in the investigator's judgment, pose a current suicidal or homicidal risk;
have taken any investigational drug within 30 days of baseline; and

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
TopiramateAlso: TopamaxTopiramate will be titrated over 5 weeks to a maximum dosage of 200 mg according to the following schedule: 25mg daily for days 1-7, 50mg daily for days 8-14, 75mg daily for days 15-21, 100mg daily for days 22-28, 150mg daily for days 29-35, 200mg daily for days 36-42. Maximum dosage will be maintained for 6 weeks, followed by a one-week taper-off period (100mg daily for 4 days and 50mg daily for 3 days).	Drug	Topiramate
PlaceboPlacebo/study medication will be administered in opaque capsules in an identical fashion to maintain the double-blind study design.	Drug	Placebo

Primary outcome

4-week Continuous Abstinence From Smoking
Time frame: Weeks 8-12 of treatment.
This measure indicates the proportion of participants who did or did not smoke any cigarettes during the final 4 weeks of treatment, which represented weeks 8-12 of study participation.

1 secondary outcome

Percent Relapsing to Any Drinking or Illicit Drug Use
Time frame: 12-week treatment phase, 36-week combined treatment and follow-up

Results and safety

Results posted to the registry on 31 Jan 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
Topiramate	65	63
Placebo	67	66

Primary outcome: 4-week Continuous Abstinence From Smoking

Time frame: Weeks 8-12 of treatment.. Number. Unit: percentage of participants abstinent

Measure	Topiramate n = 63	Placebo n = 66
Value	7.9	10.6

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Topiramate	1 of 63 (1.6%)	46 of 63 (73%)	Not reported
Placebo	3 of 66 (4.5%)	49 of 66 (74.2%)	Not reported

Limitations and caveats (from the sponsor): Dually-dependent male smokers with high rates of SUDs and psychiatric disorders, thus not generalizable to other populations; topiramate dose lower than the dose found to reduce smoking in active alcoholics; attrition may have impacted results.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28029173Anthenelli RM, Heffner JL, Wong E, Tibbs J, Russell K, Isgro M, Dinh E, Wehrle C, Worley MJ, Doran N. A Randomized Trial Evaluating Whether Topiramate Aids Smoking Cessation and Prevents Alcohol Relapse in Recovering Alcohol-Dependent Men. Alcohol Clin Exp Res. 2017 Jan;41(1):197-206. doi: 10.1111/acer.13279. Epub 2016 Dec 28.
Click here for more information about this study: Topiramate to Aid Smoking Cessation in Recovering Alcohol Dependent MenLink 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.

Robert M. Anthenelli, MD principal investigator

VA San Diego Healthcare System, San Diego, CA

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 Topiramate in people with Nicotine Dependence and Alcohol Dependence, run by VA Office of Research and Development 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 7 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 31 Jan 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 31 Jan 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?

4-week Continuous Abstinence From Smoking (time frame: Weeks 8-12 of treatment.). 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 NCT00802412, 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 31 Jan 2017.