Naltrexone for Medication Compliance Among HIV-infected M... | NCT01377168

Studies
Naltrexone for Medication Compliance Among HIV-infected Men With Alcohol Use Disorder

NCT01377168

Sponsor

Fred Hutchinson Cancer Center

Status

Completed

Last Update Posted

Jun 16, 2017Actual

Enrollment

159Actual

Phase

Phase 4

Conditions

HIV
Alcohol Use Disorder

Interventions

oral naltrexone
Placebo pill

Countries

Peru

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2014

Primary Completion Date

Jun 2016Actual

Completion Date

Jun 2017Actual

First Submitted Date

Jun 17, 2011

First Submission Date that Met QC Criteria

Jun 17, 2011

First Posted Date

Jun 21, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 14, 2017

Last Update Posted Date

Jun 16, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ann C Duerr, Member, Fred Hutchinson Cancer CenterPrincipal Investigator

Lead Sponsor

Fred Hutchinson Cancer CenterOTHER

Collaborators

Name	Class
Yale University	OTHER
Asociación Civil Impacta Salud y Educación, Peru	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study will recruit 159 HIV-infected men with alcohol use disorders (AUDs). Men will be randomized to receive either oral naltrexone for the treatment of alcohol use disorder or placebo. Men with acute, recent or established HIV infection will receive antiretroviral treatment (ART) and be randomized to oral naltrexone or placebo. The purpose of this study is to see whether use of oral naltrexone improves medication compliance, and therefore HIV viral load suppression, among men with alcohol use disorder. The study will also assess the impact of oral naltrexone on alcohol use behaviors in this population.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

159Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo pill	Placebo Comparator	Daily oral placebo.	Drug: Placebo pill
NTX	Active Comparator	Daily oral naltrexone.	Drug: oral naltrexone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
oral naltrexone	Drug		NTX	Nalerona
Placebo pill

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HIV Viral Load Suppression	The primary outcome will be the proportion with a VL<400 copies/mL at 6 months.	6 months

Secondary Outcomes

Measure	Description	Time Frame
ART Compliance and Alcohol Use Behavior	Secondary HIV outcomes will include time to ART initiation, retention on ART over 6 months, and HIV sexual risk behaviors. Alcohol use outcomes include the following: 1) Time to relapse to heavy drinking (for men defined as >5 drinks/drinking day); 2) percent of days drinking (PDD) over the six-month examination period; 3) percent of days abstinent (PDA) over the six month examination period; and 4) alcohol craving using the Obsessive Compulsive Drinking Scale where a mean change in total score will be assessed and compared between treatment groups.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Meets DSM-IV criteria for alcohol dependence or problem drinking.
Age 18 years and older
Confirmed HIV infection, either through positive HIV antibody or detectable HIV-1 RNA level.
No participation in pharmacotherapy trial in the previous 30 days
Not pregnant

Exclusion Criteria:

Unable to provide informed consent
Verbally or physically threatening to research staff
Unable to communicate in Spanish
Pending trials for a felony
Childs-Pugh Class C Cirrhosis
Grade 3 Hepatitis (LFTs > 5X normal)
Receiving opioid prescription narcotics or has pain syndrome necessitating future use of opioid prescription narcotics.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ann Duerr, MD, PhD, MPH	Fred Hutchinson Cancer Center	Principal Investigator
Frederick Altice, MD	Yale University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asociación Civil Impacta Salud y Educación		Lima			Peru

Condition Browse Module

MeSH Terms

ID	Term
D000437	Alcoholism

Ancestor Terms

ID	Term
D019973	Alcohol-Related Disorders
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009271	Naltrexone

Ancestor Terms

ID	Term
D009270	Naloxone
D009019	Morphinans
D053610	Opiate Alkaloids
D000470	Alkaloids
D006571

Browse Leaves

Not provided

Browse Branches

Not provided