Comparing Measures of Medication Taking in a Pharmacotherapy Trial for Cocaine Dependence

Mooney, Marc E; Sayre, Shelly L.; Green, Charles; Rhoades, Howard M.; Schmitz, Joy M.

doi:10.1097/01.adt.0000132509.65041.bf

Cited by 16 publications

(14 citation statements)

References 33 publications

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“…Riboflavin-based compliance rates ranged from 50% to 70% and tended to be higher than the more conservative MEMS-based rates (range 17% to 67%), consistent with discrepancies observed in other pharmacotherapy studies (Mooney et al, 2004).…”

Section: Medication Compliancesupporting

confidence: 87%

“…Adverse events were evaluated by the study nurse and physician that included a standardized reporting system when appropriate. Pill taking was observed on clinic visit days and tracked by riboflavin fluorescence testing (Del Boca et al, 1996;Mooney et al, 2004) and MEMS. Cocaine craving ratings were obtained at each visit using the Brief Substance Craving Scale (BSCS: Mezinskis et al, 1998;Mezinskis et al, 2001).…”

Section: Assessmentsmentioning

confidence: 99%

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Levodopa pharmacotherapy for cocaine dependence: Choosing the optimal behavioral therapy platform

Schmitz

Mooney

Moeller

et al. 2008

Drug and Alcohol Dependence

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112

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Background: The dopamine precursor levodopa has shown some, albeit relatively weak, promise in treating cocaine dependence. This study sought to identify the most appropriate behavioral therapy platform for levodopa pharmacotherapy by evaluating its effect when administered in combination with behavioral platforms of varying intensities. Method:A total of 161 treatment-seeking cocaine dependent subjects received sustained release levodopa/carbidopa (400/100 mg bid, Sinemet) or placebo delivered in combination with Clinical Management (ClinMan); ClinMan+Cognitive Behavioral Therapy (CBT); or ClinMan+CBT +Voucher-Based Reinforcement Therapy (VBRT) in a 12-week randomized, placebo-controlled, double-blind (for medication condition) trial. Medication compliance was monitored with riboflavin (100 mg/capsule) and the Medication Event Monitoring System. Protocol compliance was addressed in weekly, 10-minute nurse-delivered ClinMan sessions. Weekly, 1-hour CBT sessions focused on coping skills training. VBRT (with escalating reinforcer value) provided cash-valued vouchers contingent on cocaine-negative urine toxicology results. Urine benzoylecgonine assays collected thrice-weekly were analyzed by intention-to-treat criteria using generalized linear mixed models.Results: Levodopa main effects were found on all outcome measures of cocaine use. Contrasts testing the levodopa-placebo difference within each behavioral platform found reliable effects, favoring levodopa, only in the VBRT platform. Levodopa treatment with vouchers produced higher proportions of cocaine-negative urines and longer periods of consecutive abstinence compared to other treatment combinations.Conclusion: This is the first study to find a significant treatment effect for levodopa and, in doing so, to demonstrate that the magnitude of this effect is dependent upon conditions of the behavioral therapy platform. The data support use of levodopa with abstinence-based reinforcement therapy as one efficacious combination in cocaine dependence disorder treatment.

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Section: Medication Compliancesupporting

confidence: 87%

Section: Assessmentsmentioning

confidence: 99%

Levodopa pharmacotherapy for cocaine dependence: Choosing the optimal behavioral therapy platform

Schmitz

Mooney

Moeller

et al. 2008

Drug and Alcohol Dependence

Self Cite

112

View full text Add to dashboard Cite

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“…Medication adherence was determined by urinary riboflavin levels (37) and self-reports of taking capsules. Medication safety assessments included adverse event (AE) reports and weekly rating scale for side-effects.…”

Section: Methodsmentioning

confidence: 99%

PPAR‐gamma agonist pioglitazone modifies craving intensity and brain white matter integrity in patients with primary cocaine use disorder: a double‐blind randomized controlled pilot trial

et al. 2017

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Background and aims Pioglitazone (PIO), a potent agonist of PPAR-gamma, is a promising candidate treatment for cocaine use disorder (CUD). We tested the effects of PIO on targeted mechanisms relevant to CUD: cocaine craving and brain white matter (WM) integrity. Feasibility, medication compliance, and tolerability were evaluated. Design Two-arm double-blind randomized controlled proof-of-concept pilot trial of PIO or placebo (PLC). Setting Single-site outpatient treatment research clinic in Houston, Texas, USA. Participants Thirty treatment-seeking adults with CUD. Mean [standard deviation (SD)] age was 47.8 (7.45), education was 12.7 (1.5), with 19.3 (7.8) years of reported cocaine use. Eighteen of the 30 participants (8=PIO; 10=PLC) completed diffusion tensor imaging (DTI) of WM integrity at pre/post-treatment. Intervention Study medication was dispensed at thrice weekly visits along with once weekly cognitive behavioral therapy for 12 weeks. Measurements Measures of target engagement mechanisms of interest included cocaine craving assessed by the Brief Substance Craving Scale (BSCS), the Obsessive Compulsive Drug Use Scale (OCDUS), a visual analog scale (VAS), and change in WM integrity. Feasibility measures included number completing treatment, medication compliance (riboflavin detection), and tolerability (side effects, serious adverse events). Findings Target engagement change in mechanisms of interest, defined as a ≥ 0.75 Bayesian posterior probability of an interaction existing favoring PIO over PLC, was demonstrated on measures of craving (BSCS, VAS) and WM integrity indexed by fractional anisotropy (FA) values. Outcomes indicated greater decrease in craving and greater increase in FA values in the PIO group. Feasibility was demonstrated by high completion rates among those starting treatment (21/26 = 80%) and medication compliance (≥ 80%). There were no reported serious adverse events for PIO. Conclusions Compared with placebo, patients receiving pioglitazone show a higher likelihood of reduced cocaine craving and improved brain white matter integrity as a function of time in treatment. Pioglitazone shows good feasibility as a treatment for cocaine use disorder.

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“…It appeared that different articles used different cut-off points to define low-high correlations and so we could not make any aggregate quantitative assessment of correlation based on the sample of 11 studies. Table II also summarizes 19 article entries that examined the unnamed questionnaires used to measure adherence along with MEMS Ò [33][34][35][36][37][38][39][40][41][42][43][44][45][46][47][48][49][50]52] in disease states such as HIV (32%), cardiovascular conditions (11%) and others (57%). Most of the studies reported low (53%) to high (32%) correlation with MEMS Ò .…”

Section: Correlation Between Self-report and Electronic Monitoringmentioning

confidence: 99%

Concordance of Adherence Measurement Using Self-Reported Adherence Questionnaires and Medication Monitoring Devices

et al. 2010

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The primary objective of this review was to identify and examine the literature on the association between medication adherence self-reported questionnaires (SRQs) and medication monitoring devices. The primary literature search was performed for 1980-2009 using PubMed, PubMed In Process and Non-Indexed, Ovid MEDLINE, Ovid MEDLINE In-Process, PsycINFO (EBSCO), CINAHL (EBSCO), Ovid HealthStar, EMBASE (Elsevier) and Cochrane Databases and using the following search terms: 'patient compliance', 'medication adherence', 'treatment compliance', 'drug monitoring', 'drug therapy', 'electronic', 'digital', 'computer', 'monitor', 'monitoring', 'drug', 'drugs', 'pharmaceutical preparations', 'compliance' and 'medications'. We identified studies that included SRQs and electronic monitoring devices to measure adherence and focused on the SRQs that were found to be moderately to highly correlated with the monitoring devices. Of the 1679 citations found via the primary search, 41 full-text articles were reviewed for correlation between monitoring devices and SRQs. A majority (68%) of articles reported high (27%), moderate (29%) or significant (12%) correlation between monitoring devices (37 using Medication Event Monitoring System [MEMS®] and four using other devices) and SRQs (11 identified and numerous other unnamed SRQs). The most commonly used SRQs were the Adult/Pediatric AIDS Clinical Trial Group (AACTG/PACTG; 24.4%, 10/41) followed by the 4-item Morisky (9.8%, 4/41), Brief Medication Questionnaire (9.8%, 4/41) and visual analogue scale (VAS; 7.3%, 3/41). Although study designs differed across the articles, SRQs appeared to report a higher rate of medication adherence (+14.9%) than monitoring devices. In conclusion, several medication adherence SRQs were validated using electronic monitoring devices. A majority of them showed high or moderate correlation with medication adherence measured using monitoring devices, and could be considered for measuring patient-reported adherence prospectively.

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Comparing Measures of Medication Taking in a Pharmacotherapy Trial for Cocaine Dependence

Cited by 16 publications

References 33 publications

Levodopa pharmacotherapy for cocaine dependence: Choosing the optimal behavioral therapy platform

Levodopa pharmacotherapy for cocaine dependence: Choosing the optimal behavioral therapy platform

PPAR‐gamma agonist pioglitazone modifies craving intensity and brain white matter integrity in patients with primary cocaine use disorder: a double‐blind randomized controlled pilot trial

Concordance of Adherence Measurement Using Self-Reported Adherence Questionnaires and Medication Monitoring Devices

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