Alcohol DependenceINSPIRENCT01077310

Alcohol Pharmacotherapy for HIV+ Prisoners

A study testing Vivitrol- Intramuscular naltrexone (depot-formulation) in people with Alcohol Dependence and Problem Drinking, run by Yale University 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

Who is it for?: Ages 18 years and older
Conditions the study is for: Alcohol Dependence, Problem Drinking, Hazardous Drinking
What is being tested?: Vivitrol- Intramuscular naltrexone (depot-formulation)
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 100 participants
Where: 1 siteUnited States
Study dates: Aug 2010to Aug 2015
Phase: Interventional
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

HIV+
Inmates returning to New Haven or Hartford
Meets criteria for alcohol dependence (using Diagnostic and Statistical Manual IV) or problem drinking (using Alcohol Use Disorder Identification Test-AUDIT)
Gives informed consent
English or Spanish speaker
> 18 yrs

Who cannot join

On opiate pain medication or expressing need for them
Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) > 5x the upper limit of normal
Evidence of Child's Pugh Class C cirrhosis
Pending felony charges
Pregnant or unwilling to take contraceptive measures
Subject is part of another pharmacological research study

Trial locations and contacts

1 site in 1 country.

United States1 site

Yale Clinical Research
New Haven, Connecticut, 06511

Other trials in United States

About this study

Official title: Alcohol Pharmacotherapy for HIV+ Prisoners With Alcohol Dependence and Problem Drinking

This is a randomized controlled trial of injectable intramuscular naltrexone (XR-NTX) versus intramuscular placebo among HIV-infected prisoners meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for alcohol dependence or problem drinking, who are transitioning to the community and seeking treatment to prevent relapse to alcohol use. We hypothesize that extended release naltrexone (XR-NTX) will result in improved HIV outcomes (lower log10 HIV-1RNA levels and higher CD4 count) as well as improved alcohol treatment outcomes, and reduced drug/sex HIV related risk behaviors and decreased rates of reincarceration.

Read the detailed description

INSPIRE is a randomized controlled trial of injectable intramuscular NTX (XR-NTX) versus intramuscular placebo among Human Immunodeficiency (HIV) infected prisoners meeting DSM-IV criteria for alcohol dependence or problem drinking, who are transitioning to the community and seeking treatment to prevent relapse to alcohol use. While the COMBINE trial has demonstrated the effectiveness of oral naltrexone in a group of active alcohol dependent persons in decreasing relapse to alcohol use over placebo, naltrexone has not been studied in people who have a history of current alcohol dependence prior to incarceration, are incarcerated and not actively using alcohol and are likely to return to alcohol use when released. In this study, we conduct a placebo-controlled trial to determine if naltrexone has an effect in this group, which could be important in making the case for having naltrexone available to alcohol dependent or problem drinking HIV+ prisoners prior to release. We will compare their HIV treatment (HIV-1 RNA levels, CD4 count), alcohol treatment (time to relapse to heavy drinking, percent of days drinking, percent of days abstinent and alcohol craving) and HIV risk behavior (sexual and drug-related risks) outcomes. The hypotheses include:

XR-NTX will result in improved HIV clinical outcomes, including changes in HIV-1 RNA levels, and higher CD4 counts. ii. XR-NTX will result in improved alcohol treatment outcomes, including longer time to alcohol relapse, lower percent days drinking, and lower craving for alcohol.

Conditions: Alcohol Dependence, Problem Drinking, Hazardous Drinking, Human Immunodeficiency Virus, AIDS
Being tested: Vivitrol- Intramuscular naltrexone (depot-formulation), Placebo
Keywords: HIV, Acquired Immunodeficiency Syndrome, Alcohol dependence, CD4, HIV-1 RNA, Alcohol treatment outcomes
Medical subject headings: Alcoholism, Acquired Immunodeficiency Syndrome

What participants receive

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

Vivitrol- Intramuscular naltrexone (depot-formulation)Drug
Also called VIVITROL, extended release naltrexone, Intramuscular naltrexone, Depot-naltrexone
Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.
PlaceboDrug
Also called Saline
Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail. Placebo will be provided by Alkermes pharmaceuticals, the manufacturer of VIVITROL. Placebo will be identical in shape and form to active drug.

Study groups in NCT01077310
Study group	Role	What they receive
Intramuscular naltrexone	Active comparator	Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail. Receives: Drug: Vivitrol- Intramuscular naltrexone (depot-formulation)
Placebo	Placebo comparator	Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail. Receives: Drug: Placebo

What is being measured

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

Percentage of Those Maintain or Improve to HIV RNA-1 Viral Load Less Then 400 Copies/mL
Percentage of participants that maintained or improved a level of undetectable HIV viral load from baseline (closest viral load to time of release from incarceration) to 6 months post release. Missing lab values were considered to have a detectable HIV viral load.
Measured: Baseline to month 6 post release

Secondary outcomes (3)

Alcohol Treatment Outcome: Time to Alcohol Relapse
Self reported time to first heavy drinking day after release from incarceration, up to 6 months
Measured: Post release
Alcohol Treatment Outcome: Change in Average Drinks Per Drinking Day
The mean change from 12 weeks pre incarceration to 6 months post release from incarceration in average drinks per drinking day
Measured: 12 weeks prior to release from prison (baseline) to 6 months post release
Alcohol Treatment Outcome: Change in Percent of Heavy Drinking Days
change in the percent of heavy drinking days from 12 weeks prior to incarceration to 6 months post release from incarceration.
Measured: change in percent of heavy drinking days12 weeks prior to release from prison (baseline), day of release, to 6 months post-release

Timeline

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

Aug 2010Aug 2015

First posted1 Mar 2010 (estimated)
Study startAug 2010
Primary completionAug 2015
Study completionAug 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 (4)Papers the sponsor has linked to this study.
Other trials for Alcohol DependenceStudies of the same condition, open and under way.
More trials run by Yale UniversityThe 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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01077310
Sponsor's protocol ID: 0908005572
Other IDs: 1R01AA018944
Acronym: INSPIRE
Status last verified: Apr 2017
First submitted: 19 Feb 2010
Last updated: 30 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Springer SA, Altice FL, Herme M, Di Paola A. Design and methods of a double blind randomized placebo-controlled trial of extended-release naltrexone for alcohol dependent and hazardous drinking prisoners with HIV who are transitioning to the community. Contemp Clin Trials. 2014 Mar;37(2):209-18. doi: 10.1016/j.cct.2013.12.006. Epub 2013 Dec 31.
PubMed 24384538
Vagenas P, Di Paola A, Herme M, Lincoln T, Skiest DJ, Altice FL, Springer SA. An evaluation of hepatic enzyme elevations among HIV-infected released prisoners enrolled in two randomized placebo-controlled trials of extended release naltrexone. J Subst Abuse Treat. 2014 Jul;47(1):35-40. doi: 10.1016/j.jsat.2014.02.008. Epub 2014 Mar 12.
PubMed 24674234
Springer SA, Brown SE, Di Paola A, Altice FL. Correlates of retention on extended-release naltrexone among persons living with HIV infection transitioning to the community from the criminal justice system. Drug Alcohol Depend. 2015 Dec 1;157:158-65. doi: 10.1016/j.drugalcdep.2015.10.023. Epub 2015 Oct 28.
PubMed 26560326
Springer SA, Di Paola A, Barbour R, Azar MM, Altice FL. Extended-release Naltrexone Improves Viral Suppression Among Incarcerated Persons Living with HIV and Alcohol use Disorders Transitioning to the Community: Results From a Double-Blind, Placebo-Controlled Trial. J Acquir Immune Defic Syndr. 2018 Sep 1;79(1):92-100. doi: 10.1097/QAI.0000000000001759.
PubMed 29781884

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

Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
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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
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All Alcohol Dependence trials

Study at a glance

From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Alcohol Pharmacotherapy for HIV+ Prisoners With Alcohol Dependence and Problem Drinking
ClinicalTrials.gov ID: NCT01077310
Acronym / sponsor ID: INSPIRE / 0908005572
Conditions: Alcohol Dependence, Problem Drinking, Hazardous Drinking, Human Immunodeficiency Virus, AIDS
Keywords: HIV, Acquired Immunodeficiency Syndrome, Alcohol dependence, CD4, HIV-1 RNA, Alcohol treatment outcomes
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study start: Aug 2010
Primary completion: Aug 2015 (actual)
Study completion: Aug 2015 (actual)
First posted: 1 Mar 2010 (estimated)
Results: Posted 25 Nov 2016

Clinical summary

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

Detailed description

XR-NTX will result in improved HIV clinical outcomes, including changes in HIV-1 RNA levels, and higher CD4 counts. ii. XR-NTX will result in improved alcohol treatment outcomes, including longer time to alcohol relapse, lower percent days drinking, and lower craving for alcohol.

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
Intramuscular naltrexone	Active comparator	Drug: Vivitrol- Intramuscular naltrexone (depot-formulation)Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.
Placebo	Placebo comparator	Drug: PlaceboSubjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail.

Who may qualify

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

Key inclusion criteria (6 listed)

HIV+
Inmates returning to New Haven or Hartford
Meets criteria for alcohol dependence (using Diagnostic and Statistical Manual IV) or problem drinking (using Alcohol Use Disorder Identification Test-AUDIT)
Gives informed consent
English or Spanish speaker

Key exclusion criteria (6 listed)

On opiate pain medication or expressing need for them
Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) > 5x the upper limit of normal
Evidence of Child's Pugh Class C cirrhosis
Pending felony charges
Pregnant or unwilling to take contraceptive measures

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
Vivitrol- Intramuscular naltrexone (depot-formulation)Also: VIVITROL, extended release naltrexone, Intramuscular naltrexone, Depot-naltrexoneSubjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.	Drug	Intramuscular naltrexone
PlaceboAlso: SalineSubjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail. Placebo will be provided by Alkermes pharmaceuticals, the manufacturer of VIVITROL. Placebo will be identical in shape and form to active drug.	Drug	Placebo

Primary outcome

Percentage of Those Maintain or Improve to HIV RNA-1 Viral Load Less Then 400 Copies/mL
Time frame: Baseline to month 6 post release
Percentage of participants that maintained or improved a level of undetectable HIV viral load from baseline (closest viral load to time of release from incarceration) to 6 months post release. Missing lab values were considered to have a detectable HIV viral load.

3 secondary outcomes

Alcohol Treatment Outcome: Time to Alcohol Relapse
Time frame: Post release
Alcohol Treatment Outcome: Change in Average Drinks Per Drinking Day
Time frame: 12 weeks prior to release from prison (baseline) to 6 months post release
Alcohol Treatment Outcome: Change in Percent of Heavy Drinking Days
Time frame: change in percent of heavy drinking days12 weeks prior to release from prison (baseline), day of release, to 6 months post-release

Results and safety

Results posted to the registry on 25 Nov 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Extended-release Naltrexone	67	67
Placebo	33	33

Primary outcome: Percentage of Those Maintain or Improve to HIV RNA-1 Viral Load Less Then 400 Copies/mL

Time frame: Baseline to month 6 post release. Number. Unit: percent of participants

Measure	Intramuscular Naltrexone n = 67	Placebo n = 33
Value	54	42

Population analysed: Logistic regression backward stepwise models were used to find predictors of HIV viral suppression.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: full study duration, up to 48 weeks post release. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Extended-release Naltrexone	0 of 67 (0%)	9 of 67 (13.4%)	Not reported
Placebo	0 of 33 (0%)	2 of 33 (6.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 24384538Springer SA, Altice FL, Herme M, Di Paola A. Design and methods of a double blind randomized placebo-controlled trial of extended-release naltrexone for alcohol dependent and hazardous drinking prisoners with HIV who are transitioning to the community. Contemp Clin Trials. 2014 Mar;37(2):209-18. doi: 10.1016/j.cct.2013.12.006. Epub 2013 Dec 31.
Results publication: PubMed 24674234Vagenas P, Di Paola A, Herme M, Lincoln T, Skiest DJ, Altice FL, Springer SA. An evaluation of hepatic enzyme elevations among HIV-infected released prisoners enrolled in two randomized placebo-controlled trials of extended release naltrexone. J Subst Abuse Treat. 2014 Jul;47(1):35-40. doi: 10.1016/j.jsat.2014.02.008. Epub 2014 Mar 12.
Results publication: PubMed 26560326Springer SA, Brown SE, Di Paola A, Altice FL. Correlates of retention on extended-release naltrexone among persons living with HIV infection transitioning to the community from the criminal justice system. Drug Alcohol Depend. 2015 Dec 1;157:158-65. doi: 10.1016/j.drugalcdep.2015.10.023. Epub 2015 Oct 28.
Derived from this study: PubMed 29781884Springer SA, Di Paola A, Barbour R, Azar MM, Altice FL. Extended-release Naltrexone Improves Viral Suppression Among Incarcerated Persons Living with HIV and Alcohol use Disorders Transitioning to the Community: Results From a Double-Blind, Placebo-Controlled Trial. J Acquir Immune Defic Syndr. 2018 Sep 1;79(1):92-100. doi: 10.1097/QAI.0000000000001759.
Individual participant dataSharing planned: No

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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.

Sandra A Springer, MD principal investigator

Yale University

Frederick L Altice, MD principal investigator

Yale University

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

Questions about this trial

What is this clinical trial studying?

A study testing Vivitrol- Intramuscular naltrexone (depot-formulation) in people with Alcohol Dependence and Problem Drinking, run by Yale University 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 6 inclusion and 6 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 30 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Nov 2016). 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 Those Maintain or Improve to HIV RNA-1 Viral Load Less Then 400 Copies/mL (time frame: Baseline to month 6 post release). 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 NCT01077310, which also lists 4 linked publications.

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 30 May 2017.