Reduction in Heavy Drinking in Patients With HIV
Conditions
Keywords
Substance Abuse Counseling, Adherence (medication), Alcohol Abuse, Highly Active Antiretroviral Therapy (HAART), Naltrexone, Vivitrol, HIV
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.
Interventions
DRUGNaltrexone
NTX arm will receive monthly extended release NTX doses at 380mg (4 mL), administered as an intramuscular gluteal injection at 4-week intervals.
OTHERPlacebo + Medication Management/Medication Coaching
Placebo + Medication Management/Medication Coaching
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Be HIV-infected. 2. Currently be prescribed HAART medication or be eligible to receive HAART medication. 3. Report less than 95% adherence to their HAART medication. 4. 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. 5. Be at least 18 years old. 6. Be able to understand English and provide informed consent.
Exclusion criteria
1. Be psychotic or severely psychiatrically disabled. 2. Be currently enrolled in formal treatment for alcohol (excluding self-help, e.g. Alcoholics Anonymous) 3. Have medical conditions that would preclude completing or be of harm during the course of the study. 4. 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. 5. Have a known contraindication to NTX therapy (e.g. requiring opioid medication for pain). 6. Be pregnant, nursing or unable to use an effective method of birth control (women). \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo + MM/MC Placebo plus Medical Management/Medication Coaching
Placebo + Medication Management/Medication Coaching: Placebo + Medication Management/Medication Coaching | 26 |
| NTX + MM/MC 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. | 25 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Discontinued Intervention | 1 | 2 |
| Overall Study | Lost to Follow-up | 5 | 7 |
Baseline characteristics
| Characteristic | Placebo + MM/MC | NTX + MM/MC | Total |
|---|---|---|---|
| Age, Continuous | 51.2 years STANDARD_DEVIATION 9.2 | 51.2 years STANDARD_DEVIATION 7.6 | 51.2 years STANDARD_DEVIATION 8.2 |
| Alcohol Abuse/Dependence | 17 Participants | 18 Participants | 35 Participants |
| ANY Drinking Days in past 30 Days | 19.2 days STANDARD_DEVIATION 7.5 | 14.8 days STANDARD_DEVIATION 8.7 | 17.9 days STANDARD_DEVIATION 8.8 |
| ART Adherence | .59 proportion of days adherent STANDARD_DEVIATION 0.31 | .51 proportion of days adherent STANDARD_DEVIATION 0.33 | .55 proportion of days adherent STANDARD_DEVIATION 0.32 |
| CD4 count | 513 cells/mm3 STANDARD_DEVIATION 423 | 457 cells/mm3 STANDARD_DEVIATION 313 | 487 cells/mm3 STANDARD_DEVIATION 374 |
| Drug Abuse/Dependence | 19 Participants | 20 Participants | 39 Participants |
| Heavy Drinking Days in past 30 Days | 16.4 days STANDARD_DEVIATION 8.4 | 11.3 days STANDARD_DEVIATION 8.4 | 14.7 days STANDARD_DEVIATION 9.8 |
| Prior Alcohol or Drug Treatment | 15 Participants | 17 Participants | 32 Participants |
| Prior Receipt for Medications to Help with Drinking Acamprosate | 0 Participants | 1 Participants | 1 Participants |
| Prior Receipt for Medications to Help with Drinking Disulfiram | 1 Participants | 2 Participants | 3 Participants |
| Prior Receipt for Medications to Help with Drinking Naltrexone | 2 Participants | 0 Participants | 2 Participants |
| Prior Receipt for Medications to Help with Drinking Overall | 3 Participants | 3 Participants | 6 Participants |
| Race/Ethnicity, Customized Black-non-Hispanic | 19 Participants | 17 Participants | 36 Participants |
| Race/Ethnicity, Customized Hispanic | 3 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized White-non-Hispanic | 2 Participants | 6 Participants | 8 Participants |
| Region of Enrollment United States | 26 participants | 25 participants | 51 participants |
| Sex: Female, Male Female | 7 Participants | 8 Participants | 15 Participants |
| Sex: Female, Male Male | 19 Participants | 17 Participants | 36 Participants |
| Undetectable HIV Viral Load | 16 Participants | 10 Participants | 26 Participants |
| VACS Score | 44 units on a scale STANDARD_DEVIATION 26 | 42 units on a scale STANDARD_DEVIATION 26 | 43 units on a scale STANDARD_DEVIATION 26 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 25 |
| other Total, other adverse events | 4 / 26 | 3 / 25 |
| serious Total, serious adverse events | 3 / 26 | 6 / 25 |
Outcome results
Primary
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.
Time frame: One year
Population: data were analyzed intention to treat where all observations were included in the analyses, including those only measured at baseline.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo + MM/MC | HAART Adherence | 12 Weeks | 7 Participants |
| Placebo + MM/MC | HAART Adherence | 36 Weeks | 8 Participants |
| Placebo + MM/MC | HAART Adherence | 24 Weeks | 6 Participants |
| Placebo + MM/MC | HAART Adherence | 52 Weeks | 6 Participants |
| NTX + MM/MC | HAART Adherence | 52 Weeks | 3 Participants |
| NTX + MM/MC | HAART Adherence | 12 Weeks | 4 Participants |
| NTX + MM/MC | HAART Adherence | 24 Weeks | 4 Participants |
| NTX + MM/MC | HAART Adherence | 36 Weeks | 4 Participants |
Secondary
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.
Time frame: One year
Population: data were analyzed intention to treat where all observations were included in the analyses, including those only measured at baseline.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo + MM/MC | Heavy Drinking Days | 12 Weeks | 8.4 days | Standard Deviation 6.8 |
| Placebo + MM/MC | Heavy Drinking Days | 24 Weeks | 5.4 days | Standard Deviation 8.4 |
| Placebo + MM/MC | Heavy Drinking Days | 36 Weeks | 4.2 days | Standard Deviation 5 |
| Placebo + MM/MC | Heavy Drinking Days | 52 Weeks | 5.8 days | Standard Deviation 8.3 |
| NTX + MM/MC | Heavy Drinking Days | 52 Weeks | 0.3 days | Standard Deviation 4.9 |
| NTX + MM/MC | Heavy Drinking Days | 12 Weeks | 1.7 days | Standard Deviation 4.7 |
| NTX + MM/MC | Heavy Drinking Days | 36 Weeks | 0.5 days | Standard Deviation 2 |
| NTX + MM/MC | Heavy Drinking Days | 24 Weeks | 0.1 days | Standard Deviation 5.3 |