Dataset Information

Opioid Misuse as a Predictor of Alcohol Treatment Outcomes in the COMBINE Study: Mediation by Medication Adherence.

ABSTRACT: BACKGROUND:Alcohol is often consumed with opioids and alcohol misuse interferes with treatment for opioid use disorder (OUD). Drug misuse is associated with worse alcohol use disorder (AUD) treatment outcomes, yet no studies have investigated the role of opioid misuse in AUD treatment outcomes. METHODS:We conducted secondary analyses of the medication conditions of the COMBINE study (n = 1,226), a randomized clinical trial of medications (acamprosate and/or naltrexone) and behavioral interventions (medication management and/or behavioral intervention) for alcohol dependence. We examined associations between baseline opioid misuse and the use of cannabis and other drugs with time to first drinking day, time to first heavy drinking day, and the frequency and intensity of drinking during treatment and 1 year following treatment, based on latent profile analysis. Opioid misuse was defined as use of illicit or prescription opioids without a prescription or not as directed in the previous 6 months, in the absence of OUD. Self-reported cannabis and other drug use were also examined. Seventy individuals (5.7%) met the opioid misuse definition and 542 (44.2%) reported use of cannabis or other drugs without opioid misuse. We also examined medication adherence as a potential mediator. RESULTS:Baseline opioid misuse significantly predicted the time to first heavy drinking day (OR = 1.38 [95% CI: 1.13, 1.64], p = 0.001) and a higher probability of being in a heavier and more frequent drinking profile at the end of treatment (OR = 2.90 [95% CI: 1.43, 5.90], p = 0.003), and at 1 year following treatment (OR = 2.66 [95% CI: 1.26, 5.59], p = 0.01). Cannabis and other drug use also predicted outcomes. Medication adherence partially mediated the association between opioid misuse, cannabis use, other drug use, and treatment outcomes. CONCLUSIONS:Opioid misuse and other drug use were associated with poorer AUD treatment outcomes, which was partially mediated by medication adherence. Clinicians and researchers should assess opioid misuse and other drug use in patients undergoing AUD treatment.

SUBMITTER: Witkiewitz K

PROVIDER: S-EPMC6063524 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature

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Opioid Misuse as a Predictor of Alcohol Treatment Outcomes in the COMBINE Study: Mediation by Medication Adherence.

Witkiewitz Katie K Votaw Victoria R VR Vowles Kevin E KE Kranzler Henry R HR

Alcoholism, clinical and experimental research 20180609 7

<h4>Background</h4>Alcohol is often consumed with opioids and alcohol misuse interferes with treatment for opioid use disorder (OUD). Drug misuse is associated with worse alcohol use disorder (AUD) treatment outcomes, yet no studies have investigated the role of opioid misuse in AUD treatment outcomes.<h4>Methods</h4>We conducted secondary analyses of the medication conditions of the COMBINE study (n = 1,226), a randomized clinical trial of medications (acamprosate and/or naltrexone) and behavio ...[more]

PMID: 29873089

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Project description:OBJECTIVE:To evaluate the full range of alcohol treatment effectiveness, it is important to assess secondary nondrinking outcome dimensions in addition to primary alcohol consumption outcomes. METHOD:We used a large sample (n=1,226) of alcohol-dependent participants entering the National Institute on Alcohol Abuse and Alcoholism-sponsored COMBINE (Combining Medications and Behavioral Interventions) Study, a multisite clinical trial of pharmacological (naltrexone [ReVia] and acamprosate [Campral]) and behavioral interventions, to examine the effects of specific treatment combinations on nondrinking functional outcomes. We assessed the outcomes at baseline and at the end of 16 weeks of alcohol treatment and again at the 26-week and/or 52-week postrandomization follow-ups. RESULTS:(1) Drinking and secondary outcomes were significantly related, especially at the follow-up periods. A higher percentage of heavy drinking days, more drinks per drinking day, and lower percentage of days abstinent were associated with lower quality-of-life measures. (2) All nondrinking outcomes showed improvement at the end of 16 weeks of treatment and most maintained improvement over the 26-week and 52-week follow-ups. Only two measures returned to pretreatment levels at 52 weeks: percentage of days paid for work and physical health. Improvements of nondrinking outcomes remained even after adjusting for posttreatment heavy drinking status. (3) Although nondrinking outcomes showed overall improvement, specific pharmacological and behavioral treatment combinations were not differentially effective on specific secondary outcomes. CONCLUSIONS:In the current study, changes that resulted from treatment were multidimensional, and improvements in nondrinking outcomes reflected the overall significant improvement in drinking but they were not differentiated between treatment combination groups. Findings from this study support the importance of including secondary nondrinking outcomes in clinical alcohol-treatment trials.

Project description:ContextNaltrexone hydrochloride treatment for alcohol dependence works for some individuals but not for everyone. Asn40Asp, a functional polymorphism of the mu-opioid receptor gene (OPRM1), might predict naltrexone response.ObjectiveTo evaluate whether individuals with alcoholism who are heterozygous (Asp40/Asn40) or homozygous (Asp40/Asp40) for the OPRM1 Asp40 allele respond better to naltrexone.DesignPharmacogenetic analysis conducted between January 1, 2001, and January 31, 2004.SettingEleven academic sites in the COMBINE Study.ParticipantsRecently abstinent volunteers who met all 3 of the following conditions: (1) DSM-IV criteria for primary alcohol dependence; (2) participation in the COMBINE Study; and (3) availability of DNA.InterventionsAlcoholic subjects were treated for 16 weeks with 100 mg of naltrexone hydrochloride (234 Asn40 homozygotes and 67 with at least 1 copy of the Asp40 allele) or placebo (235 Asn40 homozygotes and 68 with at least 1 copy of the Asp40 allele). All participants received medical management (MM) alone or with combined behavioral intervention (CBI).Main outcome measuresTime trends in percentage of days abstinent, percentage of heavy drinking days, and rates of good clinical outcome.ResultsAlcoholic subjects with an Asp40 allele receiving MM alone (no CBI) had an increased percentage of days abstinent (P = .07) and a decreased percentage of heavy drinking days (P = .04) if treated with naltrexone vs placebo, while those with the Asn40/Asn40 genotype showed no medication differences. If treated with MM alone and naltrexone, 87.1% of Asp40 carriers had a good clinical outcome, compared with only 54.8% of individuals with the Asn40/Asn40 genotype (odds ratio, 5.75; confidence interval, 1.88-17.54), while, if treated with placebo, 48.6% of Asp40 carriers and 54.0% of individuals with the Asn40/Asn40 genotype had a good clinical outcome (interaction between medication and genotype, P = .005). No gene x medication interactions were observed in those treated with both MM and CBI.ConclusionsThese results confirm and extend the observation that the functionally significant OPRM1 Asp40 allele predicts naltrexone treatment response in alcoholic individuals. This relationship might be obscured, however, by other efficacious treatments. OPRM1 genotyping in alcoholic individuals might be useful to assist in selecting treatment options.Trial registrationclinicaltrials.gov Identifier: NCT00006206.

Project description:OBJECTIVES:Community pharmacy continues to play a crucial role in the national response to the opioid epidemic. The purpose of this article is to describe the protocol for a pilot study that is examining the feasibility and acceptability of the Motivational Intervention-Medication Therapy Management (MI-MTM) model. This study also examines the preliminary clinical effect of MI-MTM for improving opioid medication misuse and patient activation in self-management of health conditions that increase risk for misuse. DESIGN:MI-MTM is a pharmacy-based integrated care model made up of 4 evidence-based practices: medication therapy management; brief motivational intervention; patient navigation; and naloxone training and referral. To test MI-MTM compared with Standard Medication Counseling (SMC), we are conducting a 2-group randomized single-blinded controlled trial with assessments at 3 time points. SETTING AND PARTICIPANTS:The study is being conducted within a western Pennsylvania university-based community pharmacy with 46 patients with opioid misuse (MI-MTM = 23; SMC = 23). MAIN OUTCOME MEASURES:Feasibility will be measured by capturing patient completion rate of MI-MTM sessions. Acceptability will be measured by administering satisfaction surveys regarding pharmacist and patient navigator services. Acceptability will also be captured by conducting intensive qualitative interviews. Preliminary effect of the intervention on misuse will be measured with the use of the Prescription Opioid Misuse Index and the Opioid Compliance Checklist. Activation in self-management will be measured with the use of the Patient Activation Measure. RESULTS:This project is currently recruiting, and results are to come. CONCLUSION:This study is the first in the United States to implement an evidence-based integrated behavioral intervention into the community pharmacy setting to address opioid medication misuse among pharmacy patients. The results of this study will provide necessary foundational data that allow further testing of this intervention model in a larger trial.

Project description:BACKGROUND:Patients recovering from opioid use disorders (OUD) may be prone to relapse and opioid misuse in the postoperative period due to re-exposure to prescription opioids for pain control. This retrospective study analyzed the incidence of confirmed opioid misuse in the postoperative period in patients with OUDs enrolled in an opioid agonist treatment (OAT) program. METHODS:The study population was US veterans with a diagnosis of OUD who enrolled in the OAT program at VA Maryland Health Care System (Baltimore, Maryland, USA) between 1/1/2000 and 12/31/2016. The patients were excluded if they were enrolled in OAT for less than a year, or if they had surgery within the first 180 days after OAT admission. The surgical group consisted of veterans who had surgery or an invasive procedure during their enrollment in the OAT program. The control (reference) group consisted of enrolled veterans who did not have any invasive procedure. The primary outcome was the first opioid misuse within 365?days after surgery date in the surgical group or a randomly assigned sham surgery date in controls. Opioid misuse was defined as either inappropriate use of opioids detected via urinalysis or admission with a diagnosis of an opioid overdose. RESULTS:From a total of 1352 patients enrolled in the OAT program, 413 were excluded because they were enrolled for less than a year, and 26 were excluded because they had surgery within the first 180?days after admission to the OAT program. Of the 923 eligible patients, 87 had surgery while enrolled and 836 did not. Using propensity scores, all 87 of the surgical cases were matched to 249 of the control cases. In the matched groups, surgery was positively associated with postoperative opioid misuse (odds ratio (OR) of 1.91, 95% CI 1.05-3.48, p?=?0.034) in logistic regression. CONCLUSION:Among patients with a history of opioid use disorders, the postoperative period was associated with an increased risk of opioid misuse. Moreover, opioid misuse among patients in an opioid agonist treatment program may well be considered a surgical hazard.

Project description:Medication nonadherence after liver transplantation (LT) is associated with adverse clinical outcomes such as graft rejection and graft loss. Few studies have examined nonadherence and its impact on clinical outcomes in LT. The study objectives were (1) to evaluate medication understanding (with treatment knowledge and demonstrated regimen use scores) and medication adherence or nonadherence to entire regimens among LT recipients and (2) to examine associations of these exposures with clinical outcomes. We conducted a 2-site study of 105 recipients between 2011 and 2012 at 2 transplant centers in Chicago, IL and Atlanta, GA. Data were collected via detailed, in-person interviews and medical record reviews. Study participants were middle-aged and predominantly male; 15% of the sample had limited literacy. On average, patients were taking 11 medications [standard deviation (SD)?=?4], and 39% had undergone a medication change within the last month. The average scores for the entire medication regimen were 86% (SD?=?22%) for treatment knowledge and 78% (SD?=?22%) for demonstrated regimen use. The mean score for self-reported nonadherence to the entire regimen was 14% (SD?=?20%), whereas 32% of the patients were nonadherent according to tacrolimus levels. In multivariate analyses, lower income, less time since transplantation, a higher number of medications, and limited literacy were inversely associated with treatment knowledge scores (all P?<?0.05), whereas limited literacy was associated with nonadherence according to tacrolimus levels (P?<?0.05). In multivariate models, higher scores for treatment knowledge [incidence rate ratio (IRR)?=?0.85, 95% confidence interval (CI)?=?0.74-0.97] and demonstrated regimen use (IRR?=?0.87, 95% confidence interval?=?0.77-0.98) were independently associated with 15% and 13% reductions in the number of posttransplant rehospitalizations, respectively. Inadequate treatment knowledge and improper regimen use may be significant determinants of unintentional nonadherence among LT recipients and are associated with adverse clinical outcomes.

Dataset Information

Opioid Misuse as a Predictor of Alcohol Treatment Outcomes in the COMBINE Study: Mediation by Medication Adherence.

Publications

Opioid Misuse as a Predictor of Alcohol Treatment Outcomes in the COMBINE Study: Mediation by Medication Adherence.

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