DAWN: Reducing Heavy Drinking to Optimize HIV/AIDS Treatment and Prevention
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Study Design
Arms and Interventions
| 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 Names:
|
| Placebo Comparator: Placebo + MM/MC Placebo plus Medical Management/Medication Coaching |
Other: Placebo + Medication Management/Medication Coaching
Placebo + Medication Management/Medication Coaching
|
Outcome Measures
Primary Outcome Measures
- HAART Adherence [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.
Secondary Outcome Measures
- Heavy Drinking Days [One year]
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.
Eligibility Criteria
Criteria
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).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Yale University School of Medicine | New Haven | Connecticut | United States | 06510 |
| 2 | VACT Healthcare System | New Haven | Connecticut | United States | 06516 |
Sponsors and Collaborators
- Yale University
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
- Principal Investigator: Lynn E Sullivan (Fiellin), MD, Yale University
Study Documents (Full-Text)
More Information
Publications
- 0909005730
- 1R01AA018923
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | NTX + MM/MC | Placebo + MM/MC |
|---|---|---|
| Arm/Group Description | Naltrexone + Medical Management/Medication Coaching Naltrexone: NTX arm will receive monthly extended release NTX doses at 380mg (4 mL), administered as an intramuscular gluteal injection at 4-week intervals. | Placebo plus Medical Management/Medication Coaching Placebo + Medication Management/Medication Coaching: Placebo + Medication Management/Medication Coaching |
| Period Title: Overall Study | ||
| STARTED | 25 | 26 |
| COMPLETED | 19 | 17 |
| NOT COMPLETED | 6 | 9 |
Baseline Characteristics
| Arm/Group Title | Placebo + MM/MC | NTX + MM/MC | Total |
|---|---|---|---|
| Arm/Group Description | Placebo plus Medical Management/Medication Coaching Placebo + Medication Management/Medication Coaching: Placebo + Medication Management/Medication Coaching | Naltrexone + Medical Management/Medication Coaching Naltrexone: NTX arm will receive monthly extended release NTX doses at 380mg (4 mL), administered as an intramuscular gluteal injection at 4-week intervals. | Total of all reporting groups |
| Overall Participants | 26 | 25 | 51 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
51.2
(9.2)
|
51.2
(7.6)
|
51.2
(8.2)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
7
26.9%
|
8
32%
|
15
29.4%
|
| Male |
19
73.1%
|
17
68%
|
36
70.6%
|
| Race/Ethnicity, Customized (Count of Participants) | |||
| White-non-Hispanic |
2
7.7%
|
6
24%
|
8
15.7%
|
| Black-non-Hispanic |
19
73.1%
|
17
68%
|
36
70.6%
|
| Hispanic |
3
11.5%
|
1
4%
|
4
7.8%
|
| Other |
2
7.7%
|
1
4%
|
3
5.9%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
26
100%
|
25
100%
|
51
100%
|
| ART Adherence (proportion of days adherent) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [proportion of days adherent] |
.59
(.31)
|
.51
(.33)
|
.55
(.32)
|
| Undetectable HIV Viral Load (Count of Participants) | |||
| Count of Participants [Participants] |
16
61.5%
|
10
40%
|
26
51%
|
| CD4 count (cells/mm3) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [cells/mm3] |
513
(423)
|
457
(313)
|
487
(374)
|
| VACS Score (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
44
(26)
|
42
(26)
|
43
(26)
|
| Heavy Drinking Days in past 30 Days (days) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [days] |
16.4
(8.4)
|
11.3
(8.4)
|
14.7
(9.8)
|
| ANY Drinking Days in past 30 Days (days) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [days] |
19.2
(7.5)
|
14.8
(8.7)
|
17.9
(8.8)
|
| Alcohol Abuse/Dependence (Count of Participants) | |||
| Count of Participants [Participants] |
17
65.4%
|
18
72%
|
35
68.6%
|
| Drug Abuse/Dependence (Count of Participants) | |||
| Count of Participants [Participants] |
19
73.1%
|
20
80%
|
39
76.5%
|
| Prior Alcohol or Drug Treatment (Count of Participants) | |||
| Count of Participants [Participants] |
15
57.7%
|
17
68%
|
32
62.7%
|
| Prior Receipt for Medications to Help with Drinking (Count of Participants) | |||
| Overall |
3
11.5%
|
3
12%
|
6
11.8%
|
| Naltrexone |
2
7.7%
|
0
0%
|
2
3.9%
|
| Acamprosate |
0
0%
|
1
4%
|
1
2%
|
| Disulfiram |
1
3.8%
|
2
8%
|
3
5.9%
|
Outcome Measures
| Title | HAART Adherence |
|---|---|
| Description | 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. |
| Time Frame | One year |
Outcome Measure Data
| Analysis Population Description |
|---|
| data were analyzed intention to treat where all observations were included in the analyses, including those only measured at baseline. |
| Arm/Group Title | Placebo + MM/MC | NTX + MM/MC |
|---|---|---|
| Arm/Group Description | Placebo plus Medical Management/Medication Coaching Placebo + Medication Management/Medication Coaching: Placebo + Medication Management/Medication Coaching | Naltrexone + Medical Management/Medication Coaching Naltrexone: NTX arm will receive monthly extended release NTX doses at 380mg (4 mL), administered as an intramuscular gluteal injection at 4-week intervals. |
| Measure Participants | 26 | 25 |
| 12 Weeks |
7
26.9%
|
4
16%
|
| 24 Weeks |
6
23.1%
|
4
16%
|
| 36 Weeks |
8
30.8%
|
4
16%
|
| 52 Weeks |
6
23.1%
|
3
12%
|
| Title | Heavy Drinking Days |
|---|---|
| Description | 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. |
| Time Frame | One year |
Outcome Measure Data
| Analysis Population Description |
|---|
| data were analyzed intention to treat where all observations were included in the analyses, including those only measured at baseline. |
| Arm/Group Title | Placebo + MM/MC | NTX + MM/MC |
|---|---|---|
| Arm/Group Description | Placebo plus Medical Management/Medication Coaching Placebo + Medication Management/Medication Coaching: Placebo + Medication Management/Medication Coaching | Naltrexone + Medical Management/Medication Coaching Naltrexone: NTX arm will receive monthly extended release NTX doses at 380mg (4 mL), administered as an intramuscular gluteal injection at 4-week intervals. |
| Measure Participants | 26 | 25 |
| 12 Weeks |
8.4
(6.8)
|
1.7
(4.7)
|
| 24 Weeks |
5.4
(8.4)
|
0.1
(5.3)
|
| 36 Weeks |
4.2
(5.0)
|
0.5
(2.0)
|
| 52 Weeks |
5.8
(8.3)
|
0.3
(4.9)
|
Adverse Events
| Time Frame | Adverse events were collected up through the 1 year follow up period. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Placebo + MM/MC | NTX + MM/MC | ||
| Arm/Group Description | Placebo plus Medical Management/Medication Coaching Placebo + Medication Management/Medication Coaching: Placebo + Medication Management/Medication Coaching | Naltrexone + Medical Management/Medication Coaching Naltrexone: NTX arm will receive monthly extended release NTX doses at 380mg (4 mL), administered as an intramuscular gluteal injection at 4-week intervals. | ||
All Cause Mortality |
||||
| Placebo + MM/MC | NTX + MM/MC | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/26 (0%) | 0/25 (0%) | ||
Serious Adverse Events |
||||
| Placebo + MM/MC | NTX + MM/MC | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/26 (11.5%) | 6/25 (24%) | ||
| Cardiac disorders | ||||
| Chest Pain | 0/26 (0%) | 0 | 2/25 (8%) | 2 |
| Gastrointestinal disorders | ||||
| Nausea | 0/26 (0%) | 0 | 1/25 (4%) | 2 |
| General disorders | ||||
| Intoxication | 3/26 (11.5%) | 6 | 0/25 (0%) | 0 |
| Hepatobiliary disorders | ||||
| Blood Clot | 0/26 (0%) | 0 | 1/25 (4%) | 1 |
| Infections and infestations | ||||
| Foot Infection | 0/26 (0%) | 0 | 1/25 (4%) | 1 |
| Injury, poisoning and procedural complications | ||||
| Spinal Injury | 0/26 (0%) | 0 | 1/25 (4%) | 1 |
| Nervous system disorders | ||||
| Seizure | 0/26 (0%) | 0 | 1/25 (4%) | 1 |
| Loss of Consciousness | 0/26 (0%) | 0 | 1/25 (4%) | 2 |
| Hand Paralysis | 0/26 (0%) | 0 | 1/25 (4%) | 1 |
| Psychiatric disorders | ||||
| Hallucination | 0/26 (0%) | 0 | 1/25 (4%) | 1 |
| Suicidal Thoughts | 1/26 (3.8%) | 1 | 0/25 (0%) | 0 |
| Reproductive system and breast disorders | ||||
| Testicular Inflammation | 0/26 (0%) | 0 | 1/25 (4%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| Placebo + MM/MC | NTX + MM/MC | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/26 (15.4%) | 3/25 (12%) | ||
| Injury, poisoning and procedural complications | ||||
| Fall Related Injury | 4/26 (15.4%) | 4 | 3/25 (12%) | 3 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Lynn Fiellin |
|---|---|
| Organization | Yale School of Medicine |
| Phone | 203-737-3347 |
| lynn.fiellin@yale.edu |
- 0909005730
- 1R01AA018923