Acceptability and feasibility of a randomized clinical trial of oral naltrexone vs. placebo for women living with HIV infection: Study design challenges and pilot study results

Cook, Robert L.; Weber, Kathleen M.; Mai, D.; Thoma, Kathleen A.; Hu, Xingdi; Brumback, Babette; Karki, Manju; Bryant, Kendall; Rathore, Mobeen H.; Young, Mary; Cohen, Mardge H.

doi:10.1016/j.cct.2017.06.012

Cited by 10 publications

(16 citation statements)

References 26 publications

(21 reference statements)

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“…As shown in Table 1, two of these studies have used oral naltrexone (NTX) [44,49] and the 5 other used extendedrelease injectable form (XR-NTX) [45][46][47][48]50]. The difference between reported outcomes and a small number of studies has made it difficult to present results in a metaanalysis.…”

Section: Resultsmentioning

confidence: 99%

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Effectiveness of naltrexone treatment for alcohol use disorders in HIV: a systematic review

Farhadian

Moradi

Zamanian

et al. 2020

Subst Abuse Treat Prev Policy

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Background: Because alcohol use disorders (AUDs) in patients living with HIV/AIDS are associated with a reduction in therapeutic outcomes and increases the risk of morbidity/mortality, finding an appropriate pharmacotherapy treatment for this disorder is necessary. Objectives: This systematic review contains studies that examine the effects of pharmacological intervention (oral naltrexone (NTX) or injectable extended-release naltrexone (XR-NTX)) on the persons living with HIV and AUDs. Methods: A systematic literature search using three electronic databases including Pubmed Medline, Scopus and the Cochrane Library and Google Scholar was conducted and includes articles published from 1995 to 2019. Records were collected by searching relevant keywords and those that meet the inclusion/exclusion criteria are included. Results: Overall, in this systematic review, the results of 7 relevant studies including pilot and randomized controlled/ clinical trials were summarized and reviewed. Among selected records 2 of these assessed the efficacy of NTX and 5 tested the XR-NTX effectiveness in treating AUDs among persons living with HIV (PLH). In summary, with some expectations, NTX and XR-NTX administration in persons living with HIV and AUDs led to reduced alcohol use, improved viral suppression, unchanged ART adherence and has no significant adverse events. Conclusion: The findings of this systematic review suggest the beneficial effects and safety of the NTX and XR-NTX for treating AUDs in PLH. Further studies are needed in the future to focus on the treatment of AUDs in people living with HIV.

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Section: Resultsmentioning

confidence: 99%

“…Of the 51 participants who enrolled in the study by Edelman et al, 2019, only 23 participants remained in the study for up to 24 weeks [45]. 82% of Cook et al, 2017 study participants completed the course of treatment [44]. Among 51 people with HIV/AUD enrolled in the study by Korthuis.…”

Section: Evaluated Outcomes Treatment Retentionmentioning

confidence: 99%

Effectiveness of naltrexone treatment for alcohol use disorders in HIV: a systematic review

Farhadian

Moradi

Zamanian

et al. 2020

Subst Abuse Treat Prev Policy

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“…Women in this study may have chosen to participate in a clinical trial related to drinking because they were already interested in quitting. Although we did not directly inquire whether participants were treatment‐seeking, many participants may have been interested in reducing or stopping their drinking and waiting for the right opportunity to attempt to change their drinking (Cook et al., ). All women received multiple assessments related to alcohol consumption and its consequences, and reliable evidence suggests that repeated assessments alone can have an impact on overall drinking behavior (McCambridge and Kypri, ).…”

Section: Discussionmentioning

confidence: 99%

“…We previously completed a pilot study to demonstrate that WLWH were willing to enroll in a clinical trial of naltrexone versus placebo and that many women could successfully reduce their drinking during the study (Cook et al., ). We selected naltrexone rather than other existing medications because it can be taken once daily and is generally well tolerated (Jonas et al., ; Maisel et al., ), and because it can be used to support either alcohol reduction or complete cessation (Tidey et al., ).…”

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confidence: 99%

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

Zhou

Míguez

et al. 2019

Alcoholism Clin & Exp Res

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Background: Alcohol consumption is associated with poor health outcomes in women living with HIV (WLWH), but whether medication can help to reduce drinking in non-treatment-seeking women or whether reduction in drinking improves HIV outcomes is unclear. We conducted a randomized clinical trial (RCT) of daily oral naltrexone (50 mg) versus placebo in WLWH who met criteria for current unhealthy alcohol use.Methods: WLWH with current unhealthy alcohol use (>7 drinks/wk or >3 drinks/occasion) were randomly assigned to daily oral naltrexone 50 mg (n = 96) or placebo (n = 98) for 4 months. Drinking outcomes, including the proportion of women who reduced (

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“…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%

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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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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Acceptability and feasibility of a randomized clinical trial of oral naltrexone vs. placebo for women living with HIV infection: Study design challenges and pilot study results

Cited by 10 publications

References 26 publications

Effectiveness of naltrexone treatment for alcohol use disorders in HIV: a systematic review

Effectiveness of naltrexone treatment for alcohol use disorders in HIV: a systematic review

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

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

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