Reduction in Drinking was Associated With Improved Clinical Outcomes in Women With HIV Infection and Unhealthy Alcohol Use: Results From a Randomized Clinical Trial of Oral Naltrexone Versus Placebo

Cook, Robert L.; Zhou, Zhi; Míguez, María José; Quiros, Clery; Espinoza, Luis; Lewis, John E.; Brumback, Babette; Bryant, Kendall

doi:10.1111/acer.14130

Cited by 20 publications

(24 citation statements)

References 44 publications

(47 reference statements)

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“…The retention rates in the WHAT-IF? study was above satisfactory, with over 89% and 85% completing the 4-month and 7-month follow-ups respectively (Cook et al, 2019). This is notable and does suggest that positive experiences in the study could enhance study retention.…”

Section: Introductionmentioning

confidence: 77%

“…To date, the WHAT-IF? study was the rst clinical trial to examine pharmacotherapy for a reduction in hazardous drinking among a sample of women with HIV (Cook et al, 2019). While the majority of women in the WHAT-IF?…”

Section: Discussionmentioning

confidence: 99%

“…While the majority of women in the WHAT-IF? study were Black/African-American, the inclusion of minority women in alcohol intervention research is scarce (Cook et al, 2019;Yancey et al, 2006;Vidaver et al, 2000). To address this shortcoming, the successful recruitment of women and minorities may require additional planning, timelines, and budget requirements (Myles et al, 2019;Daunt, 2003;Vidaver et al, 2000;Yancey et al, 2006).…”

Section: Discussionmentioning

confidence: 99%

“…The WHAT-IF study was a large, multi-site double-blind randomized clinical trial that evaluated pharmacotherapy for a reduction in drinking among women with HIV in Miami, FL. Detailed information about the study is published elsewhere (Cook et al, 2019;Cook et al, 2017). Brie y, the primary goal of the study was a reduction in hazardous drinking, de ned as consuming >7 drinks per week or >3 drinks in one sitting.…”

Section: Methodsmentioning

confidence: 99%

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Recruitment, experience, and retention among women with HIV and hazardous drinking enrolled a randomized clinical trial

Canidate

Cook

Varma

et al. 2020

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Abstract Background: Despite efforts by the NIH to enhance the participation of women and minorities in clinical research, women with HIV continue to remain underrepresented in alcohol intervention research. The purpose of this study is to better understand the reasons why women with HIV and hazardous drinking participated in the WHAT-IF? Study and to discuss their experience (positive or negative) in the study. Methods: Convenience and theoretical sampling were used to recruit women with HIV and hazardous drinking to complete qualitative interviews. These women had previously completed a clinical alcohol intervention trial and had consented to be contacted in the future for study-related purposes. The biopsychosocial model was used to frame the interview questions that assessed multiple determinants of drinking behavior and helped explain linkages to broader health constructs. Results: A total of 20 women with HIV and hazardous drinking completed the qualitative interview. Several factors were identified by the women as influential in their decision to participate in the WHAT-IF? study, such as the ability to quit or reduce their drinking to nonhazardous levels (biological), the ability to gain knowledge or a greater understanding of the negative effects of hazardous drinking on HIV disease progression (psychological), and peer pressure and monetary compensation (social). Also, the women identified factors (positive or negative) associated with their clinical trial experience, such as the effects of the study medication on the woman's body (biological), thoughts and feelings toward study procedures (i.e. medication, lab work, study assessments) and the length of the study (psychological), and the interactions with the WHAT-IF? Study staff (social). Conclusion: Recruiting and retaining women with HIV in alcohol intervention research remains a challenge. Findings from this study suggest that women with HIV who are hazardous drinkers may benefit from participating in research studies that could help them to reduce or quit their drinking, increase their knowledge about specific behavior changes, and earn monetary compensation. Also, positive staff interactions may be instrumental in retaining minority women in alcohol intervention research.

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Section: Introductionmentioning

confidence: 77%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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Recruitment, experience, and retention among women with HIV and hazardous drinking enrolled a randomized clinical trial

Canidate

Cook

Varma

et al. 2020

Preprint

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“…(Will Having Alcohol Treatment Improve my Functioning) study. Detailed information about the study is published elsewhere (Cook et al, 2019;Cook et al, 2017). The WHAT-IF study was a large, multi-site double-blind randomized clinical trial that evaluated pharmacotherapy for a reduction in drinking among women with HIV in Miami, FL.…”

Section: Methodsmentioning

confidence: 99%

Recruitment, experience, and retention among women with HIV and hazardous drinking enrolled in the WHAT-IF? Study

Canidate

Cook

Varma

et al. 2020

Preprint

View full text Add to dashboard Cite

Background: Despite efforts by the NIH to enhance the participation of women and minorities in clinical research, women with HIV continue to remain underrepresented in alcohol intervention research. The purpose of this study is to better understand the reasons why women with HIV and hazardous drinking participated in the WHAT-IF? Study and to discuss their experience (positive or negative) in the study.Methods: Convenience and theoretical sampling were used to recruit women with HIV and hazardous drinking to complete qualitative interviews. These women had previously completed a clinical alcohol intervention trial and had consented to be contacted in the future for study-related purposes. The biopsychosocial model was used to frame the interview questions that assessed multiple determinants of drinking behavior and helped explain linkages to broader health constructs.Results: A total of 20 women with HIV and hazardous drinking completed the qualitative interview. Several factors were identified by the women as influential in their decision to participate in the WHAT-IF? study, such as the ability to quit or reduce their drinking to nonhazardous levels (biological), the ability to gain knowledge or a greater understanding of the negative effects of hazardous drinking on HIV disease progression (psychological), and peer pressure and monetary compensation (social). Also, the women identified factors (positive or negative) associated with their clinical trial experience, such as the effects of the study medication on the woman's body (biological), thoughts and feelings toward study procedures (i.e. medication, lab work, study assessments) and the length of the study (psychological), and the interactions with the WHAT-IF? Study staff (social).Conclusion: Recruiting and retaining women with HIV in alcohol intervention research remains a challenge. Findings from this study suggest that women with HIV who are hazardous drinkers may benefit from participating in research studies that could help them to reduce or quit their drinking, increase their knowledge about specific behavior changes, and earn monetary compensation. Also, positive staff interactions may be instrumental in retaining minority women in alcohol intervention research.

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Pharmacotherapy for Alcohol Use Disorder

McPheeters,

O’Connor,

Riley

et al. 2023

JAMA

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ImportanceAlcohol use disorder affects more than 28.3 million people in the United States and is associated with increased rates of morbidity and mortality.ObjectiveTo compare efficacy and comparative efficacy of therapies for alcohol use disorder.Data SourcesPubMed, the Cochrane Library, the Cochrane Central Trials Registry, PsycINFO, CINAHL, and EMBASE were searched from November 2012 to September 9, 2022 Literature was subsequently systematically monitored to identify relevant articles up to August 14, 2023, and the PubMed search was updated on August 14, 2023.Study SelectionFor efficacy outcomes, randomized clinical trials of at least 12 weeks’ duration were included. For adverse effects, randomized clinical trials and prospective cohort studies that compared drug therapies and reported health outcomes or harms were included.Data Extraction and SynthesisTwo reviewers evaluated each study, assessed risk of bias, and graded strength of evidence. Meta-analyses used random-effects models. Numbers needed to treat were calculated for medications with at least moderate strength of evidence for benefit.Main Outcomes and MeasuresThe primary outcome was alcohol consumption. Secondary outcomes were motor vehicle crashes, injuries, quality of life, function, mortality, and harms.ResultsData from 118 clinical trials and 20 976 participants were included. The numbers needed to treat to prevent 1 person from returning to any drinking were 11 (95% CI, 1-32) for acamprosate and 18 (95% CI, 4-32) for oral naltrexone at a dose of 50 mg/d. Compared with placebo, oral naltrexone (50 mg/d) was associated with lower rates of return to heavy drinking, with a number needed to treat of 11 (95% CI, 5-41). Injectable naltrexone was associated with fewer drinking days over the 30-day treatment period (weighted mean difference, −4.99 days; 95% CI, −9.49 to −0.49 days) Adverse effects included higher gastrointestinal distress for acamprosate (diarrhea: risk ratio, 1.58; 95% CI, 1.27-1.97) and naltrexone (nausea: risk ratio, 1.73; 95% CI, 1.51-1.98; vomiting: risk ratio, 1.53; 95% CI, 1.23-1.91) compared with placebo.Conclusions and RelevanceIn conjunction with psychosocial interventions, these findings support the use of oral naltrexone at 50 mg/d and acamprosate as first-line pharmacotherapies for alcohol use disorder.

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Reduction in Drinking was Associated With Improved Clinical Outcomes in Women With HIV Infection and Unhealthy Alcohol Use: Results From a Randomized Clinical Trial of Oral Naltrexone Versus Placebo

Cited by 20 publications

References 44 publications

Recruitment, experience, and retention among women with HIV and hazardous drinking enrolled a randomized clinical trial

Recruitment, experience, and retention among women with HIV and hazardous drinking enrolled a randomized clinical trial

Recruitment, experience, and retention among women with HIV and hazardous drinking enrolled in the WHAT-IF? Study

Pharmacotherapy for Alcohol Use Disorder

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