Reduction in Heavy Drinking in Patients With HIVPhase 2/3DAWNNCT01227044

Reducing Heavy Drinking to Optimize HIV/AIDS Treatment and Prevention

A Phase 2/3 study testing Naltrexone in people with Reduction in Heavy Drinking in Patients With HIV, run by Yale University at 2 sites 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: Reduction in Heavy Drinking in Patients With HIV
What is being tested?: Naltrexone
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 51 participants
Where: 2 sitesUnited States
Study dates: Apr 2011to Aug 2017
Phase: Phase 2/3
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

Be HIV-infected.
Currently be prescribed HAART medication or be eligible to receive HAART medication.
Report less than 95% adherence to their HAART medication.
Report heavy drinking 4 or more times in the past 4 weeks, or meet current criteria for alcohol abuse or dependence. Heavy drinking is defined as 4 or more drinks for women and 5 or more drinks for men on one occasion.
Be at least 18 years old.
Be able to understand English and provide informed consent.

Who cannot join

Be psychotic or severely psychiatrically disabled.
Be currently enrolled in formal treatment for alcohol (excluding self-help, e.g. Alcoholics Anonymous)
Have medical conditions that would preclude completing or be of harm during the course of the study.
Have laboratory or clinical evidence of significant liver dysfunction (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 5 times the upper limit of the normal range) or cirrhosis with a Child-Pugh classification greater than A or B.
Have a known contraindication to NTX therapy (e.g. requiring opioid medication for pain).
Be pregnant, nursing or unable to use an effective method of birth control (women).
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Trial locations and contacts

2 sites in 1 country.

United States2 sites

Yale University School of Medicine
New Haven, Connecticut, 06510
VACT Healthcare System
New Haven, Connecticut, 06516

Other trials in United States

About this study

This is a double-blind placebo-controlled study to evaluate the effect of Naltrexone (NTX) and counseling on highly active antiretroviral treatment (HAART) medication adherence in a cohort of HIV-infected patients who report heavy drinking, or meet criteria for alcohol abuse and/or dependence, and inadequate (< 95%) HAART adherence. All patients will receive a behavioral intervention, termed Medical Management/Medication Coaching or MM/MC. MM/MC incorporates the behavioral platform Medical Management (MM) from the National Institute on Alcohol Abuse and Alcoholism (NIAAA)-funded COMBINE Study to reduce heavy alcohol use with Medication Coaching (MC), a manualized treatment designed to improve HAART medication adherence in HIV-infected patients with substance use disorders.

Conditions: Reduction in Heavy Drinking in Patients With HIV
Being tested: Naltrexone, Placebo + Medication Management/Medication Coaching
Keywords: Substance Abuse Counseling, Adherence (medication), Alcohol Abuse, Highly Active Antiretroviral Therapy (HAART), Naltrexone, Vivitrol, HIV
Medical subject headings: Medication Adherence, Alcoholism

What participants receive

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

NaltrexoneDrug
Also called Vivitrol
NTX arm will receive monthly extended release NTX doses at 380mg (4 mL), administered as an intramuscular gluteal injection at 4-week intervals.
Placebo + Medication Management/Medication CoachingOther
Placebo + Medication Management/Medication Coaching

Study groups in NCT01227044
Study group	Role	What they receive
NTX + MM/MC	Active comparator	Naltrexone + Medical Management/Medication Coaching Receives: Drug: Naltrexone
Placebo + MM/MC	Placebo comparator	Placebo plus Medical Management/Medication Coaching Receives: Other: Placebo + Medication Management/Medication Coaching

What is being measured

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

HAART Adherence
The intent of this outcome is to compare the efficacy of NTX +MM/MC versus placebo +MM/MC on adherence to HAART. It is hypothesized that NTX +MM/MC will lead to improved adherence to HAART when compared to placebo + MM/MC.
Measured: One year

Secondary outcomes (1)

Heavy Drinking Days
This outcome is intended to compare the efficacy of NTX +MM/MC versus placebo +MM/MC in reducing days of heavy drinking. It is hypothesized that NTX +MM/MC will lead to greater reductions in the number of days of heavy drinking when compared to placebo + MM/MC.
Measured: One year

Timeline

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

Apr 2011Aug 2017

First posted22 Oct 2010 (estimated)
Study startApr 2011
Primary completionAug 2017
Study completionAug 2017

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 Reduction in Heavy Drinking in Patients With HIVStudies 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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01227044
Sponsor's protocol ID: 0909005730
Other IDs: 1R01AA018923
Acronym: DAWN
Status last verified: Mar 2019
First submitted: 20 Oct 2010
Last updated: 21 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Edelman EJ, Moore BA, Holt SR, Hansen N, Kyriakides TC, Virata M, Brown ST, Justice AC, Bryant KJ, Fiellin DA, Fiellin LE. Efficacy of Extended-Release Naltrexone on HIV-Related and Drinking Outcomes Among HIV-Positive Patients: A Randomized-Controlled Trial. AIDS Behav. 2019 Jan;23(1):211-221. doi: 10.1007/s10461-018-2241-z.
PubMed 30073637

Study at a glance

From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Reducing Heavy Drinking to Optimize HIV/AIDS Treatment and Prevention
ClinicalTrials.gov ID: NCT01227044
Acronym / sponsor ID: DAWN / 0909005730
Conditions: Reduction in Heavy Drinking in Patients With HIV
Keywords: Substance Abuse Counseling, Adherence (medication), Alcohol Abuse, Highly Active Antiretroviral Therapy (HAART), Naltrexone, Vivitrol, HIV
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study start: Apr 2011
Primary completion: Aug 2017 (actual)
Study completion: Aug 2017 (actual)
First posted: 22 Oct 2010 (estimated)
Results: Posted 21 Mar 2019

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: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
NTX + MM/MC	Active comparator	Drug: NaltrexoneNaltrexone + Medical Management/Medication Coaching
Placebo + MM/MC	Placebo comparator	Other: Placebo + Medication Management/Medication CoachingPlacebo plus Medical Management/Medication Coaching

Who may qualify

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

Key inclusion criteria (6 listed)

Be HIV-infected.
Currently be prescribed HAART medication or be eligible to receive HAART medication.
Report less than 95% adherence to their HAART medication.
Report heavy drinking 4 or more times in the past 4 weeks, or meet current criteria for alcohol abuse or dependence. Heavy drinking is defined as 4 or more drinks for women and 5 or more drinks for men on one occasion.
Be at least 18 years old.

Key exclusion criteria (7 listed)

Be psychotic or severely psychiatrically disabled.
Be currently enrolled in formal treatment for alcohol (excluding self-help, e.g. Alcoholics Anonymous)
Have medical conditions that would preclude completing or be of harm during the course of the study.
Have laboratory or clinical evidence of significant liver dysfunction (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 5 times the upper limit of the normal range) or cirrhosis with a Child-Pugh classification greater than A or B.
Have a known contraindication to NTX therapy (e.g. requiring opioid medication for pain).

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
NaltrexoneAlso: VivitrolNTX arm will receive monthly extended release NTX doses at 380mg (4 mL), administered as an intramuscular gluteal injection at 4-week intervals.	Drug	NTX + MM/MC
Placebo + Medication Management/Medication CoachingPlacebo + Medication Management/Medication Coaching	Other	Placebo + MM/MC

Primary outcome

HAART Adherence
Time frame: One year
The intent of this outcome is to compare the efficacy of NTX +MM/MC versus placebo +MM/MC on adherence to HAART. It is hypothesized that NTX +MM/MC will lead to improved adherence to HAART when compared to placebo + MM/MC.

1 secondary outcome

Heavy Drinking Days
Time frame: One year

Results and safety

Results posted to the registry on 21 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
NTX + MM/MC	25	19
Placebo + MM/MC	26	17

Primary outcome: HAART Adherence

Time frame: One year. Count of participants. Unit: Participants

Measure	Placebo + MM/MC n = 26	NTX + MM/MC n = 25
12 Weeks	7	4
24 Weeks	6	4
36 Weeks	8	4
52 Weeks	6	3

Population analysed: data were analyzed intention to treat where all observations were included in the analyses, including those only measured at baseline.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collected up through the 1 year follow up period.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo + MM/MC	3 of 26 (11.5%)	4 of 26 (15.4%)	0 of 26
NTX + MM/MC	6 of 25 (24%)	3 of 25 (12%)	0 of 25

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 30073637Edelman EJ, Moore BA, Holt SR, Hansen N, Kyriakides TC, Virata M, Brown ST, Justice AC, Bryant KJ, Fiellin DA, Fiellin LE. Efficacy of Extended-Release Naltrexone on HIV-Related and Drinking Outcomes Among HIV-Positive Patients: A Randomized-Controlled Trial. AIDS Behav. 2019 Jan;23(1):211-221. doi: 10.1007/s10461-018-2241-z.

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.

Lynn E Sullivan (Fiellin), MD principal investigator

Yale University

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

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Naltrexone in people with Reduction in Heavy Drinking in Patients With HIV, run by Yale University at 2 sites 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 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 21 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 21 Mar 2019). 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?

HAART Adherence (time frame: One year). 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 NCT01227044, 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 21 Mar 2019; AzTrials last refreshed its copy on 6 Nov 2026.