Aberrant drug-related behavior observed during a 12-week open-label extension period of a study involving patients taking chronic opioid therapy for persistent pain and fentanyl buccal tablet or traditional short-acting opioid for breakthrough pain.
Pain Med
; 15(8): 1365-72, 2014 Aug.
Article
en En
| MEDLINE
| ID: mdl-24666664
ABSTRACT
OBJECTIVE:
Evaluate aberrant drug-related behaviors in patients administering fentanyl buccal tablet or traditional short-acting opioids for breakthrough pain.DESIGN:
Twelve-week open-label extension.SETTING:
Forty-two US sites.SUBJECTS:
Opioid-tolerant patients with chronic pain who completed the previous randomized, double-blind, crossover portion of a study comparing fentanyl buccal tablet and immediate-release oxycodone for treatment of breakthrough pain.METHODS:
Patients were rerandomized to continue treatment with fentanyl buccal tablet or begin any traditional short-acting opioid. Assessments included Screener and Opioid Assessment for Patients with Pain-Revised (SOAPP-R) at baseline and Addiction Behaviors Checklist and Current Opioid Misuse Measure at baseline and final visit. Case report forms were reviewed retrospectively to identify aberrant drug-related behaviors.RESULTS:
One hundred thirty patients entered the open-label extension (fentanyl buccal tablet, N = 65; traditional short-acting opioid, N = 65). SOAPP-R scores were <18 (low risk of aberrant drug-related behavior) in 74% of patients; no significant differences in SOAPP-R scores were observed between treatment groups. At the final visit, ≤14% of patients in each treatment group had scores indicating potential aberrant drug-related behavior (Addiction Behaviors Checklist ≥3, Current Opioid Misuse Measure ≥9); no significant differences in scores were observed between treatment groups. Baseline SOAPP-R score ≥18 was not predictive of Addiction Behaviors Checklist ≥3 but was predictive of Current Opioid Misuse Measure ≥9. Aberrant behaviors were identified in 12 (18%) fentanyl buccal tablet patients and 13 (20%) traditional short-acting opioid patients.CONCLUSIONS:
Incidence of aberrant drug-related behaviors was similar between patients taking fentanyl buccal tablet and traditional short-acting opioids over 12 weeks.Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Fentanilo
/
Dolor Irruptivo
/
Dolor Crónico
/
Analgésicos Opioides
/
Trastornos Relacionados con Opioides
Tipo de estudio:
Clinical_trials
/
Observational_studies
/
Prognostic_studies
/
Risk_factors_studies
Límite:
Female
/
Humans
/
Male
/
Middle aged
Idioma:
En
Revista:
Pain Med
Asunto de la revista:
NEUROLOGIA
/
PSICOFISIOLOGIA
Año:
2014
Tipo del documento:
Article
País de afiliación:
Estados Unidos