Bipolar DisorderPhase 1/2NCT00302133

Optimizing Pharmacotherapy for Bipolar Alcoholics

A Phase 1/2 study testing Naltrexone hydrochloride in people with Bipolar Disorder and Alcohol Dependence, run by University of Miami 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 test the efficacy of naltrexone and valproate in the treatment of comorbid bipolar disorder and alcohol dependence. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Bipolar Disorder, Alcohol Dependence
What is being tested?: Naltrexone hydrochloride
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 88 participants
Where: 1 siteUnited States
Study dates: May 2006to Jul 2013
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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subjects will meet Diagnostic and Statistical Manual-IV (DSM-IV) criteria for current alcohol dependence and a concurrent bipolar disorder

Who cannot join

1) Schizophrenia, schizoaffective and any nonbipolar psychotic disorder, unipolar major depression, primary anxiety disorder,mental retardation and signs of impaired cognitive functioning.
2) Opiate dependence, abuse, or on opioid maintenance treatment for any reason and those with positive urine screen for opiate.
3)Current DSM-IV criteria for dependence on substances other that alcohol, cannabis,nicotine or caffeine.
4) Neurological conditions including epilepsy, history of brain injury,encephalitis or any organic brain syndrome or documented focally abnormal EEG.
5)Medical conditions including severe cardiac, liver, kidney, endocrine, hematologic, or other impairing medical conditions, or impending surgery
6)Pregnancy
7)Inability or unwillingness to use contraceptive methods
8)Any medical condition or other reason that in the opinion of the investigator would prevent the subject from completing the protocol

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Miami Miller School of Medicine
Miami, Florida, 33136

Other trials in United States

About this study

The purpose of this study is to test the efficacy of naltrexone and valproate in the treatment of comorbid bipolar disorder and alcohol dependence.

Read the detailed description

Bipolar disorder has the highest rate of association with alcohol and other substance use disorders. This complex clinical presentation is asociated with severe disabilities,morbidity and heightened risk for suicide. There is a significant gap in our knowledge regarding effective treatment interventions for this high risk clinical population. This proposal will test the efficacy of a promising pharmacological approach for the treatment of comorbid alcohol dependence and bipolar disorder. We propose a randomized, double blind, placebo controlled 12-week trial to test the efficacy of valproate plus naltrexone vs. valproate alone in decreasing alcohol use and stabilizing mood symptoms among patients with comorbid alcohol dependence and bipolar disorder. All participants receive supportive psychosocial treatment.

Conditions: Bipolar Disorder, Alcohol Dependence
Being tested: Naltrexone hydrochloride, Placebo
Keywords: Alcoholism Bipolar Disorder Pharmacotherapy Naltrexone
Medical subject headings: Bipolar Disorder, Alcoholism

What participants receive

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

Naltrexone hydrochlorideDrug
Also called Revia
Naltrexone hydrochloride 50 mg capsule daily for 12 weeks
PlaceboOther
Placebo arm

Study groups in NCT00302133
Study group	Role	What they receive
Naltrexone add on to valproate	Experimental	Naltrexone hydrochloride 50 mg capsule daily for 12 weeks add on to valproate Receives: Drug: Naltrexone hydrochloride
Placebo add on to valproate	Placebo comparator	Placebo comparator one capsule daily for 12 weeks add on to valproate Receives: Other: Placebo

What is being measured

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

Mean Number of Standard Drinks Per Drinking Day During the Last 4 Weeks of the Trial
Measured: 12 weeks

Secondary outcomes (1)

% Subjects Abstinent
Proportion of subjects abstinent during the last 4 weeks of the trial
Measured: 12 weeks

Timeline

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

May 2006Jul 2013

First posted13 Mar 2006 (estimated)
Study startMay 2006
Primary completionApr 2013
Study completionJul 2013

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 Bipolar DisorderStudies of the same condition, open and under way.
More trials run by University of MiamiThe 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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 88 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00302133
Sponsor's protocol ID: RO1-AA015385-01 -Salloum
Other IDs: R01AA015385-01
Status last verified: Apr 2016
First submitted: 9 Mar 2006
Last updated: 17 May 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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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Psychophysiological Responses to Six Single-Session Self-Regulation Interventions in a Female Adult With ADHD and Stabilized Bipolar Disorder
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Active, not recruitingPhase 2/3
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The COSMYC Trial (COmbined Suppression of MYC)
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All Bipolar Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Optimizing Pharmacotherapy for Bipolar Alcoholics
ClinicalTrials.gov ID: NCT00302133
Acronym / sponsor ID: RO1-AA015385-01 -Salloum
Conditions: Bipolar Disorder, Alcohol Dependence
Keywords: Alcoholism Bipolar Disorder Pharmacotherapy Naltrexone
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 88 participants (actual)
Lead sponsor: University of MiamiUniversity, hospital or other
Study start: May 2006
Primary completion: Apr 2013 (actual)
Study completion: Jul 2013 (actual)
First posted: 13 Mar 2006 (estimated)
Results: Posted 5 Nov 2014

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 test the efficacy of naltrexone and valproate in the treatment of comorbid bipolar disorder and alcohol dependence.

Detailed description

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
Naltrexone add on to valproate	Experimental	Drug: Naltrexone hydrochlorideNaltrexone hydrochloride 50 mg capsule daily for 12 weeks add on to valproate
Placebo add on to valproate	Placebo comparator	Other: PlaceboPlacebo comparator one capsule daily for 12 weeks add on to valproate

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Subjects will meet Diagnostic and Statistical Manual-IV (DSM-IV) criteria for current alcohol dependence and a concurrent bipolar disorder

Key exclusion criteria (8 listed)

1) Schizophrenia, schizoaffective and any nonbipolar psychotic disorder, unipolar major depression, primary anxiety disorder,mental retardation and signs of impaired cognitive functioning.
2) Opiate dependence, abuse, or on opioid maintenance treatment for any reason and those with positive urine screen for opiate.
3)Current DSM-IV criteria for dependence on substances other that alcohol, cannabis,nicotine or caffeine.
4) Neurological conditions including epilepsy, history of brain injury,encephalitis or any organic brain syndrome or documented focally abnormal EEG.
5)Medical conditions including severe cardiac, liver, kidney, endocrine, hematologic, or other impairing medical conditions, or impending surgery

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
Naltrexone hydrochlorideAlso: ReviaNaltrexone hydrochloride 50 mg capsule daily for 12 weeks	Drug	Naltrexone add on to valproate
PlaceboPlacebo arm	Other	Placebo add on to valproate

Primary outcome

Mean Number of Standard Drinks Per Drinking Day During the Last 4 Weeks of the Trial
Time frame: 12 weeks

1 secondary outcome

% Subjects Abstinent
Time frame: 12 weeks

Results and safety

Results posted to the registry on 5 Nov 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Naltrexone	9	5
Placebo	9	5

Primary outcome: Mean Number of Standard Drinks Per Drinking Day During the Last 4 Weeks of the Trial

Time frame: 12 weeks. Mean (Standard Deviation). Unit: standard drinks/drinking day

Measure	Naltrexone n = 8	Placebo n = 8
Value	0.6 (1.8)	3.8 (4.2)

Population analysed: One subject in the naltrexone group was considered an outlier and excluded from the analysis as it will disproportionally skew the results of small sample size, and one subject in the placebo group was lost to follow-up immediately after group allocation and before any first post allocation assessment.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events reported by subjects during their participation in the study. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Naltrexone	0 of 9 (0%)	5 of 9 (55.6%)	Not reported
Placebo	0 of 9 (0%)	5 of 9 (55.6%)	Not reported

Limitations and caveats (from the sponsor): High early drop-out rate leading to small number of subjects analyzed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Bipolar Disorder

Recruiting
Psychophysiological Responses to Six Single-Session Self-Regulation Interventions in a Female Adult With ADHD and Stabilized Bipolar Disorder
ADHD - Attention Deficit Disorder With Hyperactivity, Bipolar Affective Disorder; Remission in
Active, not recruitingPhase 2/3
Low Amplitude Pulse Seizure Therapy Versus Standard Ultra-Brief Right Unilateral Electroconvulsive Therapy
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Not yet recruitingObservational study
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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.

Ihsan M Salloum, MD, MPH principal investigator

University of Miami

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 Naltrexone hydrochloride in people with Bipolar Disorder and Alcohol Dependence, run by University of Miami 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 8 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 17 May 2016. 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 5 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?

Mean Number of Standard Drinks Per Drinking Day During the Last 4 Weeks of the Trial (time frame: 12 weeks). 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 NCT00302133.

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 17 May 2016; AzTrials last refreshed its copy on 3 Nov 2026.