Dataset Information

Mixed-methods trial of a phosphatidylethanol-based contingency management intervention to initiate and maintain alcohol abstinence in formerly homeless adults with alcohol use disorders.

ABSTRACT:

Background

Contingency management (CM) is an intervention where incentives are provided in exchange for biochemically confirmed alcohol abstinence. CM is effective at initiating alcohol abstinence, but it is less effective at maintaining long-term abstinence. Phosphatidylethanol (PEth), collected via a finger-stick, can detect alcohol use for 14-28 days. PEth allows for the development of a CM model that includes increasingly less frequent monitoring of abstinence to assist high risk groups, such as formerly homeless individuals, maintain long-term abstinence.

Aims

Investigate whether PEth-based CM intervention targeting alcohol abstinence in formerly homeless, currently housed individuals with alcohol use disorders is: (1) acceptable and feasible for housing program tenants and personnel; and is associated with increased (2) alcohol abstinence and (3) housing tenure.

Methods

Acceptability and feasibility will be assessed using a QUAL+quant mixed-methods design using qualitative interviews and quantitative measures of satisfaction and attrition. Effectiveness will be evaluated through a randomized pilot trial of 50 study participants who will receive 6 months of either treatment as usual (TAU) including incentives (e.g., gift cards) for providing blood samples (Control Condition) or TAU and incentives for negative PEth results (PEth-CM Condition). Outcomes will be assessed during the intervention and at a three-month follow-up visit. The trial will be conducted via telehealth as a result of COVID-19.

Discussion

This protocol seeks to utilize a novel alcohol biomarker to evaluate the acceptability, feasibility, and initial effectiveness of a CM model that encourages long-term abstinence in a high-risk group.

SUBMITTER: Fraser ER

PROVIDER: S-EPMC7973861 | biostudies-literature | 2021 Jun

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Mixed-methods trial of a phosphatidylethanol-based contingency management intervention to initiate and maintain alcohol abstinence in formerly homeless adults with alcohol use disorders.

Fraser Elizabeth R ER Hill-Kapturczak Nathalie N Jett Julianne J Beck Rachael R Oluwoye Oladunni O Kriegel Liat S LS Alcover Karl C KC McPherson Sterling S Cabassa Leopoldo J LJ Javors Martin M McDonell Michael G MG

Contemporary clinical trials communications 20210308

<h4>Background</h4>Contingency management (CM) is an intervention where incentives are provided in exchange for biochemically confirmed alcohol abstinence. CM is effective at initiating alcohol abstinence, but it is less effective at maintaining long-term abstinence. Phosphatidylethanol (PEth), collected via a finger-stick, can detect alcohol use for 14-28 days. PEth allows for the development of a CM model that includes increasingly less frequent monitoring of abstinence to assist high risk gro ...[more]

PMID: 33763620

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Project description:ImportanceAlcohol biomarkers can improve detection of heavy alcohol use in clinical care, yet cutoffs for phosphatidylethanol (PEth), a blood biomarker, have not been established.ObjectiveTo determine the optimal cutoff for PEth for heavy alcohol consumption in a study of middle-age and older adults.Design, setting, and participantsThis was a 4-week diagnostic study of adults with paroxysmal atrial fibrillation (AF) and current alcohol consumption, recruited from general cardiology and cardiac electrophysiology outpatient clinics from September 2014 to September 2019. Data were analyzed from October 2021 to March 2022.Main outcomes and measuresThe main aim was to determine the optimal PEth cutoff for heavy alcohol consumption, using the Secure Continuous Remote Alcohol Monitor (SCRAM) to measure transdermal alcohol. Area under the curve (AUC) for PEth-detected compared with SCRAM-detected heavy alcohol consumption in any week over the prior 4 weeks (ie, ≥3 [women] and ≥4 [men] episodes) or any estimated breath alcohol of 0.08% or greater in any week, and the PEth cutoff was calculated using the Youden J statistic. Similar analyses were conducted comparing PEth with individual drinks reported by pressing an event monitor, retrospective self-report via the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C), and using 2-week look-backs.ResultsIn this diagnostic study of 64 patients with both PEth and SCRAM measures over 4 weeks (54 [84.4%] men; mean age, 65.5 [95% CI, 62.6-68.5] years; 51 [79.7%] White), 31 (48.4%) had any SCRAM-detected heavy alcohol consumption over the 4 weeks, and the median (IQR) PEth at 4 weeks was 23 ng/mL (<limit of quantification to 60 ng/mL). The AUC for PEth vs any SCRAM-detected heavy alcohol consumption was 0.83 (95% CI, 0.72-0.93). The optimal PEth cutoff was 18.5 ng/mL (AUC, 0.83; 95% CI, 0.72-0.93), with sensitivity of 83.9% (95% CI, 66.3%-94.5%) and specificity of 72.7% (95% CI, 54.5%-86.7%). The PEth test characteristics by individual drink reporting using the event monitors and by the AUDIT-C, and by these measures and by SCRAM collected for 2-week intervals, were similar to those compared with the 4-week SCRAM.Conclusions and relevanceIn a predominately middle-age and older White male population, PEth compared well with SCRAM. A PEth cutoff of 18.5 ng/mL (or rounded to 20 ng/mL, a recommended PEth cutoff for significant alcohol consumption) can be used in clinical care to detect heavy alcohol consumption in middle-age and older men.

Project description:ObjectiveTo determine the most effective interventions in recently detoxified, alcohol dependent patients for implementation in primary care.DesignSystematic review and network meta-analysis.Data sourcesMedline, Embase, PsycINFO, Cochrane CENTRAL, ClinicalTrials.gov, and the World Health Organization's International Clinical Trials Registry Platform.Study selectionRandomised controlled trials comparing two or more interventions that could be used in primary care. The population was patients with alcohol dependency diagnosed by standardised clinical tools and who became detoxified within four weeks.Data extractionOutcomes of interest were continuous abstinence from alcohol (effectiveness) and all cause dropouts (as a proxy for acceptability) at least 12 weeks after start of intervention.Results64 trials (43 interventions) were included. The median probability of abstinence across placebo arms was 25%. Compared with placebo, the only intervention associated with increased probability of abstinence and moderate certainty evidence was acamprosate (odds ratio 1.86, 95% confidence interval 1.49 to 2.33, corresponding to an absolute probability of 38%). Of the 62 included trials that reported all cause dropouts, interventions associated with a reduced number of dropouts compared with placebo (probability 50%) and moderate certainty of evidence were acamprosate (0.73, 0.62 to 0.86; 42%), naltrexone (0.70, 0.50 to 0.98; 41%), and acamprosate-naltrexone (0.30, 0.13 to 0.67; 17%). Acamprosate was the only intervention associated with moderate confidence in the evidence of effectiveness and acceptability up to 12 months. It is uncertain whether other interventions can help maintain abstinence and reduce dropouts because of low confidence in the evidence.ConclusionsEvidence is lacking for benefit from interventions that could be implemented in primary care settings for alcohol abstinence, other than for acamprosate. More evidence from high quality randomised controlled trials is needed, as are strategies using combined interventions (combinations of drug interventions or drug and psychosocial interventions) to improve treatment of alcohol dependency in primary care.Systematic review registrationPROSPERO CRD42016049779.

Project description:Adjuvant endocrine therapy (AET) has been shown to improve survival in hormone receptor-positive breast cancer survivors, but as many as half do not complete recommended treatment. Management of medication-related side effects and engagement with providers are two potentially modifiable factors, but their associations with adherence are not well understood. The aims were to build on survey results to qualitatively explore survivors' experiences with prescribed AET to (a) describe appraisal and management of AET side effects and (b) deconstruct decisions to initiate, discontinue, or maintain AET. .The authors used a mixed-methods explanatory sequence research design with a qualitative emphasis. .Survivors were recruited from a clinical cancer registry maintained at the University of Texas Southwestern Medical Center, which includes the Harold C. Simmons Comprehensive Cancer Center (National Cancer Institute-designated), in Dallas. .452 survivors completed a survey, and 30 took part in telephone interviews. .Qualitative methods were used in which the authors recorded and transcribed interviews for analysis and used open coding to reduce data into themes. .Among adherent survivors, the themes of tolerance of side effects and perseverance were strong. Nonadherent survivors expressed more difficulty managing side effects and perceived fewer benefits when side effects were bothersome. The most common side effects mentioned by all survivors were menopausal symptoms and joint pain; less common side effects were cognitive decline and cardiac distress. Some sought advice from their oncology team. Nonadherent survivors appeared initially motivated to maintain AET but identified a tolerance limit for side effects after which a provider's recommendation was less influential in their decision to maintain or discontinue AET. .This study elucidated adherence as a complex continuum of behaviors, appraisals, and decision points. These insights may be particularly useful in counseling survivors taking AET and promoting timely delivery of clinical interventions to enhance adherence. .Nurses should be involved in the planning and implementation of clinical interventions to manage side effects and other barriers to AET adherence.

Project description:ObjectiveThe aim of present study is to quantitatively evaluate the association between different interventions and abstinence rates based on network meta-analysis.MethodFollowing PRISMA guidelines, randomized clinical trials that compared different alcoholic interventions for alcohol use disorders associated with abstinence rates in treatment sessions or/and follow-up sessions were recruited. Main data synthesis was performed by Bayesian random-effects network meta-analyses, and the relative ranking of interventions was estimated by cumulative probability P values (SUCRA). Funnel plot symmetry was used to detect publication bias. Moreover, pair-wised comparison was also conducted to determine the statistical difference and forest plots were generated to calculate the differences between the groups. The Grades of Recommendations Assessment, Development and Evaluation (GRADE) criteria were utilized for the recommendations of evidence from pairwise direct comparisons.ResultsA total of 137 RCTs containing 27,282 participants and 8 variations of psychotherapy, pharmacotherapy, contingency management, and brief intervention used as treatment interventions were included. In summary, contingency management plus psychotherapy was demonstrated to be effective and possessed the best rank of achieving the highest abstinence rate in treatment sessions (SUCRA, 0.61). Pharmacotherapy plus psychotherapy also revealed its efficacy and was associated with the highest abstinence rate in follow-up sessions (SUCRA, 0.40). More importantly, psychotherapy alone was demonstrated not to be associated with higher abstinence rates in both treatment (OR, 1.052; 95% CI, 0.907-1.220) and follow-up sessions (OR, 0.967; 95% CI, 0.552-1.693), yet pharmacotherapy seemed to be the only intervention associated with higher abstinence rates compared to controls in both sessions (treatment session: OR, 1.074; 95% CI, 1.002-1.152) (follow-up session: OR, 1.442; 95% CI, 1.094-1.900).ConclusionsContingency management plus psychotherapy and pharmacotherapy plus psychotherapy were demonstrated to be associated with the highest abstinence rates in treatment sessions and follow-up sessions, respectively. However, contingency management and pharmacotherapy seemed to be the substantial crucial factors allowing for the maintenance of the highest abstinence rates in respective sessions, although we need more evidence for further validation.

Dataset Information

Mixed-methods trial of a phosphatidylethanol-based contingency management intervention to initiate and maintain alcohol abstinence in formerly homeless adults with alcohol use disorders.

Background

Aims

Methods

Discussion

Publications

Mixed-methods trial of a phosphatidylethanol-based contingency management intervention to initiate and maintain alcohol abstinence in formerly homeless adults with alcohol use disorders.

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