title: Adverse events among patients in a behavioral treatment trial for heroin and cocaine dependence: effects of age, race, and gender.
abstract: Safety monitoring is a critical element of clinical trials evaluating treatment for substance dependence, but is complicated by participants' high levels of medical and psychiatric comorbidity. This paper describes AEs reported in a large (N = 286), 29-week outpatient study of behavioral interventions for heroin and cocaine dependence in methadone-maintained outpatients. A total of 884 AEs were reported (3.1 per patient, 0.12 per patient-week), the most common being infections (26.8%), gastrointestinal (20.5%), musculoskeletal (12.3%), and general (10%) disorders. Serious AEs were uncommon (1.6% of total). Female participants reported significantly higher rates of AEs (incidence density ratio, IDR = 1.38, p < 0.0001); lower rates of AEs were reported by African Americans (IDR = 0.73, p<0.0001) and participants over age 40 reported lower rates of AEs (IDR = 0.84, p = 0.0095). AE incidence was not associated with the study intervention or with psychiatric comorbidity. Further work is needed to adapt AE coding systems for behavioral trials for substance dependence; the standard Medical Dictionary for Regulatory Activities, International Federation of Pharmaceutical Manufacturers Associations (MedDRA) coding system used in this report did not contain a separate category for one of the most common types of AE, dental problems. Nonetheless, the data reported here should help provide a context in which investigators and IRBs can interpret the patterns of AEs they encounter.
authors.affiliation: Intramural Research Program, National Institute on Drug Abuse, 5500 Nathan Shock Drive, Baltimore, MD 21224, USA. jschroed@intra.nida.nih.gov
authors.forename: Jennifer R
authors.initials: JR
authors.lastname: Schroeder
authors.forename: John P
authors.initials: JP
authors.lastname: Schmittner
authors.forename: David H
authors.initials: DH
authors.lastname: Epstein
authors.forename: Kenzie L
authors.initials: KL
authors.lastname: Preston
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000553:Ambulatory Care; D044383:Black People / Q000523:psychology / Q000706:statistics & numerical data*; D019970:Cocaine-Related Disorders / Q000453:epidemiology / Q000208:ethnology / Q000534:rehabilitation*; D015928:Cognitive Behavioral Therapy; D003131:Combined Modality Therapy; D015897:Comorbidity; D003376:Counseling; D005260:Female; D006304:Health Status; D006556:Heroin Dependence / Q000453:epidemiology / Q000208:ethnology / Q000534:rehabilitation*; D006801:Humans; D015994:Incidence; D008297:Male; D008691:Methadone / Q000008:administration & dosage; D008875:Middle Aged; D009042:Motivation; D009294:Narcotics / Q000008:administration & dosage; D011615:Psychotherapy, Group; D012307:Risk Factors; D044465:White People / Q000523:psychology / Q000706:statistics & numerical data*; D001741:Black or African American
chemical_list: D009294:Narcotics; D008691:Methadone