Reducing Heavy Drinking to Optimize HIV/AIDS Treatment and Prevention (DAWN)
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ClinicalTrials.gov Identifier: NCT01227044 |
Recruitment Status
:
Completed
First Posted
: October 22, 2010
Last Update Posted
: January 17, 2018
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Reduction in Heavy Drinking in Patients With HIV | Drug: Naltrexone Other: Placebo + Medication Management/Medication Coaching | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 51 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Reducing Heavy Drinking to Optimize HIV/AIDS Treatment and Prevention |
Study Start Date : | April 2011 |
Actual Primary Completion Date : | August 2017 |
Actual Study Completion Date : | August 2017 |

Arm | Intervention/treatment |
---|---|
Active Comparator: NTX + MM/MC
Naltrexone + Medical Management/Medication Coaching
|
Drug: Naltrexone
NTX arm will receive monthly extended release NTX doses at 380mg (4 mL), administered as an intramuscular gluteal injection at 4-week intervals.
Other Name: Vivitrol
|
Placebo Comparator: Placebo + MM/MC
Placebo plus Medical Management/Medication Coaching
|
Other: Placebo + Medication Management/Medication Coaching
Placebo + Medication Management/Medication Coaching
|
- To compare the efficacy of NTX +MM/MC versus placebo +MM/MC on adherence to HAART. [ Time Frame: One year ]NTX +MM/MC will lead to improved adherence to HAART when compared to placebo + MM/MC.
- To compare the efficacy of NTX +MM/MC versus placebo +MM/MC in reducing days of heavy drinking. [ Time Frame: One year ]NTX +MM/MC will lead to greater reductions in the number of days of heavy drinking when compared to placebo + MM/MC.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01227044
United States, Connecticut | |
Yale University School of Medicine | |
New Haven, Connecticut, United States, 06510 | |
VACT Healthcare System | |
New Haven, Connecticut, United States, 06516 |
Principal Investigator: | Lynn E Sullivan (Fiellin), MD | Yale University |
Responsible Party: | Yale University |
ClinicalTrials.gov Identifier: | NCT01227044 History of Changes |
Other Study ID Numbers: |
0909005730 1R01AA018923 ( U.S. NIH Grant/Contract ) |
First Posted: | October 22, 2010 Key Record Dates |
Last Update Posted: | January 17, 2018 |
Last Verified: | January 2018 |
Keywords provided by Yale University:
Substance Abuse Counseling Adherence (medication) Alcohol Abuse Highly Active Antiretroviral Therapy (HAART) |
Naltrexone Vivitrol HIV |
Additional relevant MeSH terms:
Naltrexone Narcotic Antagonists Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents |