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Alcohol treatment effects on secondary nondrinking outcomes and quality of life: the COMBINE study.

ABSTRACT: 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.

SUBMITTER: LoCastro JS

PROVIDER: S-EPMC2653605 | biostudies-other | 2009 Mar

REPOSITORIES: biostudies-other

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Alcohol treatment effects on secondary nondrinking outcomes and quality of life: the COMBINE study.

LoCastro Joseph S JS Youngblood Marston M Cisler Ron A RA Mattson Margaret E ME Zweben Allen A Anton Raymond F RF Donovan Dennis M DM

Journal of studies on alcohol and drugs 20090301 2

<h4>Objective</h4>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.<h4>Method</h4>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 acampr ...[more]

PMID: 19261230

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Project description: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.

Project description:To obtain utilities (a unit of measure of a person's relative preferences for different health states compared with death or worst possible outcome) for uterine fibroids before and after treatment and to measure short-term utilities for the following uterine fibroid treatments: abdominal hysterectomy, magnetic resonance (MR) imaging-guided focused ultrasound surgery, and uterine artery embolization (UAE).This retrospective study was approved by the institutional review board and was HIPAA compliant. The waiting trade-off (WTO) method, a variation on the time trade-off (TTO) method, is used to obtain utilities for diagnostic procedures on the basis of the fact that people wait longer to avoid noxious tests and/or procedures. The WTO method provides short-term quality of life tolls in terms of quality-adjusted life-weeks by scaling wait times with pre- and posttreatment utilities. Utilities for uterine fibroids before and after treatment were obtained with the TTO method and a visual analog scale (VAS) by using a questionnaire administered by means of a phone interview. WTO wait times were adjusted for quality of life with VAS and TTO utilities and a transformation of VAS. Wait times were compared by using nonparametric tests. The study participants included 62 patients who had undergone abdominal hysterectomy, 74 who had undergone UAE, and 61 who had undergone MR imaging-guided focused ultrasound surgery.Quality of life increased with all treatments. The median WTO wait time was higher for hysterectomy (21.6 weeks) than for UAE or MR imaging-guided focused ultrasound surgery (14.1 weeks for both) (P < .05). Quality-adjusted life-week tolls were smaller when scaled according to TTO than when scaled according to VAS or transformation of VAS.Quality of life increased after all fibroid treatments. WTO is feasible for assessing the quality-adjusted morbidity of treatment procedures.http://radiology.rsna.org/lookup/suppl/doi:10.1148/radiol.11100704/-/DC1.

Project description:BackgroundOne of the challenges in early-stage clinical research aimed at developing novel treatments for alcohol use disorder (AUD) is that the enrolled participants are heavy drinkers, but do not seek treatment for AUD.AimsTo compare nontreatment seekers with alcohol dependence (AD) from 4 human laboratory studies conducted at Brown University (N = 240; 65.4% male) to treatment seekers with AD from the multisite COMBINE study (N = 1,383; 69.1% male) across sociodemographic and alcohol-related clinical variables and to evaluate whether the variables that significantly differentiate the 2 samples predict the 3 main COMBINE clinical outcomes: time to relapse, percent days abstinent (PDA), and good clinical outcome.MethodsSample characteristics were assessed by parametric and nonparametric testing. Three regression models measured the association between the differing variables and the 3 main COMBINE clinical outcomes.ResultsThe nontreatment seekers, compared to the treatment seekers, were more ethnically diverse, less educated, single, and working part-time or unemployed (p's < 0.05); they met fewer DSM-IV AD criteria and had significantly lower scores on alcohol-related scales (p's < 0.05); they were less likely to have a father with alcohol problems (p < 0.0001) and had a significantly earlier age of onset and longer duration of AD (p's < 0.05); they also had significantly more total drinks, drinks per drinking day, heavy drinking days (HDD), and lower PDA in the 30 days prior to baseline (p's < 0.0001 to <0.05). Having more HDD in the 30 days prior to baseline predicted all of the 3 COMBINE clinical outcomes. All the other characteristics mentioned above that differed significantly between the 2 groups predicted at least 1 of the 3 COMBINE clinical outcomes, except for level of education, age of onset, and duration of AD.ConclusionsThe observed differences between groups should be considered in efforts across participant recruitment at different stages of the development of new treatments for AUD.

Project description:BackgroundThis multicenter, randomized, double-blind, double-dummy, placebo-controlled trial primarily evaluated the efficacy of tadalafil once-daily (OaD) or on-demand ("pro-re-nata"; PRN) treatment, started early post-nsRP. Secondary outcome-measures on quality-of-life (QoL) and treatment satisfaction are reported.MethodsPatients, aged <68 yrs, with adenocarcinoma of the prostate (Gleason ≤ 7, normal preoperative erectile function [EF]) were randomized post-nsRP 1:1:1 to 9-month treatment with tadalafil 5 mg OaD, tadalafil 20 mg PRN, or placebo, followed by 6-week drug-free washout and 3-month open-label tadalafil OaD treatment (OLT). The main outcome measures were Changes in Expanded Prostate Cancer Index Composite (EPIC-26), Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS), and Self-Esteem and Relationship (SEAR) questionnaires (mixed-model-for-repeated-measures, including terms for treatment, visit, treatment-by-visit interaction, age-group, country, baseline-score). LS means with 95% confidence interval (CI) are reported.Results423 patients were randomized to 3 treatment-groups: tadalafil OaD (N = 139), PRN (N = 143), or placebo (N = 141). In each group, 57 (41.0%), 58 (40.6%), and 50 (35.5%) patients were aged 61-68 yrs. At the end of double-blind treatment (DBT), patients' EPIC sexual domain-scores improved significantly with tadalafil OaD versus placebo (treatment effect [95% CI]: 9.6 [3.1,16.0]; p = 0.004); comparisons of PRN versus placebo at end of DBT, and comparisons of tadalafil OaD and PRN versus placebo after OLT were not significant. Only in older patients (61-68 yrs; age-by-treatment p ≤ 0.1), EPIC urinary incontinence domain-scores also improved significantly with tadalafil OaD versus placebo (overall treatment effect across all visits, 8.3 [0.4,16.1]; p = 0.040). Treatment satisfaction increased significantly in both tadalafil groups, EDITS total-scores increased significantly with OaD and PRN versus placebo during DBT (p = 0.005 and p = 0.041, respectively). At the end of OLT, improvement was significant for tadalafil OaD versus placebo only (p = 0.035). No significant differences were observed for SEAR.ConclusionsThese results suggest that chronic dosing of tadalafil improves QoL of patients post-nsRP. The improvement of urinary incontinence in elderly patients randomized to tadalafil OaD may contribute to this effect.Trial registrationwww.clinicaltrials.gov , NCT01026818.

Dataset Information

Alcohol treatment effects on secondary nondrinking outcomes and quality of life: the COMBINE study.

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Alcohol treatment effects on secondary nondrinking outcomes and quality of life: the COMBINE study.

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