When worlds collide: blending the divergent traditions of pharmacotherapy and-psychotherapy outcome research.
OBJECTIVE
The multisite COMBINE Study brought together a team of alcoholism investigators who varied in whether their expertise was primarily in pharmacotherapy research or in studying psychotherapy. The process of designing a single trial that tested combinations of psychotherapy and pharmacotherapy highlighted the differences in these two research traditions and necessitated a number of compromises that are the focus of this article.


METHODS
The COMBINE trial was designed to investigate the efficacy, separately and in combination, of two medications (i.e., naltrexone, acamprosate) with Medical Management and a state-of-the-art psychotherapy, known as the Combined Behavioral Intervention.


RESULTS
Pharmacotherapy researchers favored studying outcome during the treatment period when medications were administered, viewing behavioral intervention as a means for minimizing variance during treatment and providing ethical care in placebo-controlled studies. In contrast, psychotherapy researchers focused on assessment of outcomes after treatment, regarding the behavioral intervention as a source of long-lasting change, necessitating careful training and monitoring of its implementation. The two traditions also differed on variables of interest in studying treatment process and secondary outcomes and methods of data collection and analysis. Some of the solutions reached by the COMBINE Study Research Group included studying both the short-term and long-term effects of treatment and selective inclusion of measures designed to evaluate processes specific to medications and to behavioral interventions.


CONCLUSIONS
The successful compromises reached by the COMBINE Study Research Group may be helpful to other transdisciplinary research teams undertaking a combined evaluation of promising medications and behavioral interventions for alcoholism.
Miller
William R
WR
Center on Alcoholism, Substance Abuse, and Addictions, University qf New Mexico, Albuquerque, New Mexico 87131-0001, USA. wrmiller@unm.edu
Locastro
Joseph S
JS
Longabaugh
Richard
R
O'Malley
Stephanie
S
Zweben
Allen
A
D000437:Alcoholism / Q000188:drug therapy / Q000628:therapy*; D002986:Clinical Trials as Topic; D004358:Drug Therapy / Q000379:methods*; D006801:Humans; D017063:Outcome Assessment, Health Care; D011613:Psychotherapy / Q000379:methods*; D016896:Treatment Outcome