Adverse events among patients in a behavioral treatment trial for heroin and cocaine dependence: Effects of age, race, and gender

• Published in: Drug and alcohol dependence Vol. 80; no. 1; pp. 45 - 51
• Main Authors: Schroeder, Jennifer R., Schmittner, John P., Epstein, David H., Preston, Kenzie L.
• Format: Journal Article
• Language: English
• Published: Shannon Elsevier Ireland Ltd 01.10.2005; Elsevier Science
• Subjects: Addictive behaviors; Administration, Oral; Adult; Adult and adolescent clinical studies; Ambulatory Care; Behavior therapy. Cognitive therapy; Biological and medical sciences; Black or African American; Black People - psychology; Black People - statistics & numerical data; Clinical trials; Cocaine-Related Disorders - epidemiology; Cocaine-Related Disorders - ethnology; Cocaine-Related Disorders - rehabilitation; Cognitive Behavioral Therapy; Combined Modality Therapy; Comorbidity; Counseling; Drug addiction; Female; Health Status; Heroin Dependence - epidemiology; Heroin Dependence - ethnology; Heroin Dependence - rehabilitation; Humans; Incidence; Male; Medical sciences; Methadone - administration & dosage; Middle Aged; Motivation; Narcotics - administration & dosage; Psychology. Psychoanalysis. Psychiatry; Psychopathology. Psychiatry; Psychotherapy, Group; Risk Factors; Safety; Safety monitoring; Side effects; Substance dependence; Substance dependency; Toxicology; Treatment; Treatments; White People - psychology; White People - statistics & numerical data; Safety monitoring; Clinical trials; Substance dependence; Psychotropic; Toxicity; Psychology; Sex; Ester; Dependence; Race; Complication; Clinical trial; Drug of abuse; Behavior therapy; Safety; Age; Heroin; Monitoring; Human; Drug addiction; CNS stimulant; Treatment; Addiction; Surveillance; Cocaine; Psychiatry
• ISSN: 0376-8716; 1879-0046
• DOI: 10.1016/j.drugalcdep.2005.03.007

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.