WHAT-IF: Will Having Alcohol Treatment Improve Functioning?

• Sponsor: University of Florida (Other)
• Overall Status: Completed
• CT.gov ID: NCT01245647
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
• Enrollment: 19
• Locations: 3
• Arms: 2
• Duration (Months): 23
• Patients Per Site: 6.3
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The purpose of the study is to find out if a medication,naltrexone is helpful for HIV-infected women who sometimes drink too much. The study will try to find out whether women like the medication, whether the medication helps them cut back on their drinking, and whether it helps improve their overall health. Naltrexone has not been used widely among people who are engaged in less severe drinking and in primary health care settings. Therefore, the investigators would like to determine whether it is helpful among women who sometimes drink 4 or more drinks per occasion or 7 or more drinks per week. The investigators hypothesize that by taking naltrexone, women with hazardous drinking pattern will reduce their drinking which in turn will improve their medication adherence, improve their health and quality of life.

Condition or Disease	Intervention/Treatment	Phase
HIV; Alcoholism	Drug: Naltrexone, 50mg, once per day for 4 months; Other: Sugar pill, 50mg, once per day for 4 months	Phase 2

Detailed Description

The primary objective of this study is to evaluate the acceptability and effectiveness of a treatment program for hazardous drinking, delivered within HIV-clinic outpatient settings, that involves oral naltrexone. The central hypothesis is that women randomized to the treatment program will have decreased rates of hazardous drinking and improved clinical and behavioral health outcomes that are associated with hazardous drinking. The investigators have formulated this hypotheses based on the existing literature, the preliminary data and the clinical experience. The investigators hypothesize that women randomized to receive an alcohol treatment intervention will be less likely to have hazardous drinking behavior 6-months after enrollment, compared to women who received similar assessments but no formal treatment intervention. The investigators hypothesize that 4-months after enrollment, women randomized to receive an alcohol treatment intervention will have improved adherence to HIV antiretroviral therapy, improved CD4 cell counts, reduced HIV viral load, and reduced risky sexual behavior, compared to women who receive similar assessments but no formal intervention.

The investigators will recruit 90 women from 3 different sites in Florida, Washington DC and Chicago. Of those 90 women 60 will receive naltrexone and 30 will receive placebo. Study participants will take the medication for 4 months but the investigators will follow them for 7 months. At baseline, 2 months, 4 months and 7 months, the investigators will administer study questionnaires and assess their liver enzymes, CD4 count and viral load. The investigators will also follow them up at month 1 and 3 to reinforce the medication intake and to assess for any possible side effects.

New treatment options are available, but their impact on hazardous drinking has not yet been evaluated among HIV-infected women, many of whom are poor, minorities, or who have associated mental health or substance abuse problems. Delivery of therapeutic interventions must be improved in order to reduce hazardous drinking in women with HIV/AIDS. The proposed research is significant because the therapy will be offered within HIV clinic settings and will potentially improve the health of a population that is significantly undertreated. In addition to determining the effectiveness of an alcohol treatment intervention, the investigators will also identify key barriers and facilitators associated with adherence to pharmacologic treatment for alcohol in women with hazardous drinking. The findings will directly impact the type and quality of care for hazardous drinking in this subset of HIV-infected individuals and will inform both primary and secondary prevention efforts

Study Design

• Study Type: Interventional
• Actual Enrollment: 19 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Pharmacotherapy for Hazardous Drinking in HIV Infected Women: Randomized Trial
• Study Start Date: Nov 1, 2010
• Actual Primary Completion Date: Oct 1, 2012
• Actual Study Completion Date: Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Sugar Pill, 50mg, once per day for 4 months Placebo: One third of the participants will receive placebo pills that look the same as the active comparator but are really just inert pills. Each study participant will take a single pill once a day for 4 months.	Other: Sugar pill, 50mg, once per day for 4 months; Placebo: One third of the participants will receive placebo pills that look the same as the active comparator but are really just inert pills. Each study participant will take a single pill once a day for 4 months.; Other Names: Inert sugar pill
Active Comparator: Naltrexone, 50mg, once per day for 4 months Naltrexone: Two thirds of the total study participants will receive the medication naltrexone. Each study participant will take a single pill once a day for 4 months.	Drug: Naltrexone, 50mg, once per day for 4 months; Naltrexone: Two thirds of the total study participants will receive the medication naltrexone. Each study participant will take a single pill once a day for 4 months.; Other Names: Naltrexone

Outcome Measures

Primary Outcome Measures

1. Number of Drinks Per Week [Month 4]

   Average number of standard alcohol drinks per week, as measured by timeline follow-back. A drink typically contains about 0.6 grams of alcohol, and generally represents 1 12-oz beer, 1 5-oz glass of wine, or one shot of liquor.

Secondary Outcome Measures

1. HIV Medication Adherence (95% or Better) [Month 4]

   Medication adherence was measured on a visual analogue scale ranging from 0 - 100, and indicating what percentage of the persons' HIV medication was taken on schedule over the past week (self-report). A score of 95% or better was considered adherent, and we report the proportion of persons who were adherent in each group.

2. Risky Sexual Behaviors [4 months]

   Risky sexual behavior was a dichotomous outcome for each participant at each time point, defined as having any non-condom-protected sex with a males who have an unknown/negative HIV status in the previous 30 days.

3. HIV Viral Load Suppressed [4 months]

   Viral load was classified as either suppressed (HIV viral load <50 copies/ml) or not suppressed (HIV viral load >50 copies/ml). We report the proportion of participants who had a suppressed viral load (higher number is better)

4. CD4 Count (Mean) [4 months]

   Results from CD4 cell count result obtained either as lab specifically for this study, or from lab results that were collected at the same time point for a different study or clinical indication.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Hazardous drinking: defined by the NIAAA as either of the following:

1. binge drinking (4 or more drinks per occasion at least twice monthly), (NIAAA

1. • OR

1. high quantity-frequency (>7 or drinks per week)

• Age 18 or over

• Female

• HIV-infected documented by a rapid HIV test or any licensed ELISA test kit and confirmed by a repeat ELISA, Western Blot, HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA viral load or a second antibody test by a method other than ELISA at any time prior to study entry.

• Able to understand and comply with planned study procedures.

• Willing and able to provide informed consent.

Exclusion Criteria:

• Contraindications to treatment with naltrexone: current physiologic opiate dependence; current daily prescription opioid medications; positive urine drug test for opioids; allergic to naltrexone; significantly abnormal baseline liver enzymes (AST or ALT ≥ 5 times normal); on dialysis for renal failure

• currently taking oral medications for tuberculosis.

• Currently pregnant or positive pregnancy test.

• currently breastfeeding.

• Currently taking an alcohol treatment medication (disulfiram, topiramate, naltrexone, acamprosate).

• currently homeless, unable to provide mailing address, or has plans to move from area within next 7 months.

• Unable to communicate in English.

• Research coordinator assessment that participant cannot comprehend the study or consent procedures

• Has current prognosis of less than 1 year to live

• Abnormal vital signs at enrollment visit

• Currently on treatment for Hepatitis C (HCV) infection

• Prisoner status

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Women's Interagency HIV Study	Washington	District of Columbia	United States	20007
2	University of Florida Health Science Center	Jacksonville	Florida	United States	32209
3	Women's Interagency HIV Study	Chicago	Illinois	United States	60612

Sponsors and Collaborators

• University of Florida
• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

• Principal Investigator: Robert L Cook, MD, MPH, University of Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT01245647
• Other Study ID Numbers: AA018934-01-N; R01AA018934-01
• First Posted: Nov 22, 2010
• Last Update Posted: May 7, 2018
• Last Verified: Apr 1, 2018

• Keywords provided by University of Florida: women; HIV; alcohol; medication; adherence; acceptability
• Additional relevant MeSH terms: Alcoholism; Naltrexone

Study Results

Participant Flow

Recruitment Details	We recruited participants from 3 sites in 3 cities: Washington, D.C., Chicago, and Jacksonville from December 2010 to February 2012. The last participant completed her 7-Month follow-up at October 2012.

Arm/Group Title	Sugar Pill, 50mg, Once a Day for 4 Months.	Naltrexone, 50mg, Once a Day for 4 Months
Arm/Group Description	Placebo: placebo pills looked the same as the active comparator but were really sugar pills. Each study participant in this arm took a single pill once a day for 4 months.	Naltrexone 50mg pills (single oral capsule): Each study participant in this arm took a single pill once a day for 4 months.
Period Title: Overall Study
STARTED	7	12
COMPLETED	7	8
NOT COMPLETED	0	4

Baseline Characteristics

Arm/Group Title	Sugar Pill, 50mg, Once a Day for 4 Months	Naltrexone, 50mg, Once a Day for 4 Months	Total
Arm/Group Description	Placebo: placebo pills looked the same as the active comparator but were really sugar pills. Each study participant in this arm took a single pill once a day for 4 months.	Naltrexone 50mg pills (single oral capsule): Each study participant in this arm took a single pill once a day for 4 months.	Total of all reporting groups
Overall Participants	7	12	19
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	7 100%	12 100%	19 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50.2 (9.3)	48.7 (6.6)	49.3 (7.5)
Sex: Female, Male (Count of Participants)
Female	7 100%	12 100%	19 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	7 100%	12 100%	19 100%

Outcome Measures

1. Primary Outcome

Title	Number of Drinks Per Week
Description	Average number of standard alcohol drinks per week, as measured by timeline follow-back. A drink typically contains about 0.6 grams of alcohol, and generally represents 1 12-oz beer, 1 5-oz glass of wine, or one shot of liquor.
Time Frame	Month 4

Outcome Measure Data

Analysis Population Description

All participants who provided data at the 4-month follow-up were included (n=15), which is 79% of persons who were randomized.

Arm/Group Title	Sugar Pill, 50mg, Once a Day for 4 Months.	Naltrexone, 50mg, Once a Day for 4 Months
Arm/Group Description	Placebo: placebo pills looked the same as the active comparator but were really sugar pills. Each study participant in this arm took a single pill once a day for 4 months.	Naltrexone 50mg pills (single oral capsule): Each study participant in this arm took a single pill once a day for 4 months.
Measure Participants	7	8
Mean (Standard Deviation) [standard alcohol drinks per week]	13.8 (12.4)	12.0 (16.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sugar Pill, 50mg, Once a Day for 4 Months., Naltrexone, 50mg, Once a Day for 4 Months
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.82
	Comments
	Method	t-test, 2 sided
	Comments

2. Secondary Outcome

Title	HIV Medication Adherence (95% or Better)
Description	Medication adherence was measured on a visual analogue scale ranging from 0 - 100, and indicating what percentage of the persons' HIV medication was taken on schedule over the past week (self-report). A score of 95% or better was considered adherent, and we report the proportion of persons who were adherent in each group.
Time Frame	Month 4

Outcome Measure Data

Analysis Population Description

Only persons who reported current HIV medication use (n=13) were considered for this outcome, and we included data from the 12 persons who completed the 4-month assessment.

Arm/Group Title	Sugar Pill, 50mg, Once a Day for 4 Months.	Naltrexone, 50mg, Once a Day for 4 Months
Arm/Group Description	Placebo: placebo pills looked the same as the active comparator but were really sugar pills. Each study participant in this arm took a single pill once a day for 4 months.	Naltrexone 50mg pills (single oral capsule): Each study participant in this arm took a single pill once a day for 4 months.
Measure Participants	6	6
Number [percentage of participants]	50 714.3%	50 416.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sugar Pill, 50mg, Once a Day for 4 Months., Naltrexone, 50mg, Once a Day for 4 Months
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	1.0
	Comments
	Method	Fisher Exact
	Comments

3. Secondary Outcome

Title	Risky Sexual Behaviors
Description	Risky sexual behavior was a dichotomous outcome for each participant at each time point, defined as having any non-condom-protected sex with a males who have an unknown/negative HIV status in the previous 30 days.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sugar Pill, 50mg, Once a Day for 4 Months.	Naltrexone, 50mg, Once a Day for 4 Months
Arm/Group Description	Placebo: placebo pills looked the same as the active comparator but were really sugar pills. Each study participant in this arm took a single pill once a day for 4 months.	Naltrexone 50mg pills (single oral capsule): Each study participant in this arm took a single pill once a day for 4 months.
Measure Participants	7	7
Number [percentage of persons with risky sex]	0	29

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sugar Pill, 50mg, Once a Day for 4 Months., Naltrexone, 50mg, Once a Day for 4 Months
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.46
	Comments
	Method	Fisher Exact
	Comments

4. Secondary Outcome

Title	HIV Viral Load Suppressed
Description	Viral load was classified as either suppressed (HIV viral load <50 copies/ml) or not suppressed (HIV viral load >50 copies/ml). We report the proportion of participants who had a suppressed viral load (higher number is better)
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sugar Pill, 50mg, Once a Day for 4 Months.	Naltrexone, 50mg, Once a Day for 4 Months
Arm/Group Description	Placebo: placebo pills looked the same as the active comparator but were really sugar pills. Each study participant in this arm took a single pill once a day for 4 months.	Naltrexone 50mg pills (single oral capsule): Each study participant in this arm took a single pill once a day for 4 months.
Measure Participants	7	8
Number [percentage of persons with suppressed VL]	43	88

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sugar Pill, 50mg, Once a Day for 4 Months., Naltrexone, 50mg, Once a Day for 4 Months
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.12
	Comments	no significant difference by Fisher exact test
	Method	Fisher Exact
	Comments

5. Secondary Outcome

Title	CD4 Count (Mean)
Description	Results from CD4 cell count result obtained either as lab specifically for this study, or from lab results that were collected at the same time point for a different study or clinical indication.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sugar Pill, 50mg, Once a Day for 4 Months.	Naltrexone, 50mg, Once a Day for 4 Months
Arm/Group Description	Placebo: placebo pills looked the same as the active comparator but were really sugar pills. Each study participant in this arm took a single pill once a day for 4 months.	Naltrexone 50mg pills (single oral capsule): Each study participant in this arm took a single pill once a day for 4 months.
Measure Participants	6	7
Mean (Standard Deviation) [CD4 count (cells/ml)]	669 (478)	761 (207)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sugar Pill, 50mg, Once a Day for 4 Months., Naltrexone, 50mg, Once a Day for 4 Months
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.67
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Arm/Group Title	Sugar Pill, 50 mg Once a Day for 4 Months		Naltrexone, 50mg Pill Once a Day for 4 Months
Arm/Group Description	Placebo: placebo pills looked the same as the active comparator but were really sugar pills. Each study participant in this arm took a single pill once a day for 4 months.		Naltrexone 50mg pills (single oral capsule): Each study participant in this arm took a single pill once a day for 4 months.
All Cause Mortality
	Sugar Pill, 50 mg Once a Day for 4 Months		Naltrexone, 50mg Pill Once a Day for 4 Months
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Sugar Pill, 50 mg Once a Day for 4 Months		Naltrexone, 50mg Pill Once a Day for 4 Months
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		1/12 (8.3%)
Musculoskeletal and connective tissue disorders
Muscle spasm/diarrhea/anxiety	0/7 (0%)	0	1/12 (8.3%)	1
Other (Not Including Serious) Adverse Events
	Sugar Pill, 50 mg Once a Day for 4 Months		Naltrexone, 50mg Pill Once a Day for 4 Months
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/7 (57.1%)		8/12 (66.7%)
Gastrointestinal disorders
diarrhea/upset stomach	2/7 (28.6%)	2	4/12 (33.3%)	4
General disorders
Headache	0/7 (0%)	0	4/12 (33.3%)	4
Sleepiness	1/7 (14.3%)	1	3/12 (25%)	3
Metabolism and nutrition disorders
Decreased appetite	2/7 (28.6%)	2	3/12 (25%)	3
Nervous system disorders
insomnia	1/7 (14.3%)	1	4/12 (33.3%)	4
Psychiatric disorders
Anxiety	0/7 (0%)	0	3/12 (25%)	3
Depression	2/7 (28.6%)	2	3/12 (25%)	3
Skin and subcutaneous tissue disorders
Itching	1/7 (14.3%)	1	3/12 (25%)	3

Limitations/Caveats

Sample size was very small, and 3 participants did not return for any follow-up visits; 15 completed through the Month 4 assessment, and 12 completed through Month 7. Therefore, our ability to draw conclusions based on this sample is limited.

More Information

Certain Agreements

Principal Investigators are NOT 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.