Choosing a behavioral therapy platform for pharmacotherapy of substance users

Abstract

Behavioral therapy platforms have become virtual requirements in pharmacotherapy trials due to their utility in reducing noise variability, preventing differential medication adherence and protocol attrition, enhancing statistical power and addressing ethical issues in placebo-controlled trials. Selecting an appropriate behavioral platform for a particular trial requires study-specific tailoring, taking into account both the stage of development of the medication being evaluated, as well as the specific strengths and weaknesses of a broad array of available empirically supported behavioral therapies and the range of their possible targets (e.g., enhancing medication adherence, preventing attrition, addressing co-morbid problems, fostering abstinence, and targeting specific weaknesses of the pharmacologic agent). Choosing a suitable behavioral platform also requires consideration of the characteristics of the population to be treated, stage of scientific knowledge regarding the medication's effects, appropriate balance of internal and external validity, and consideration of potential ceiling effects. Available manualized behavioral treatments are reviewed, noting their strengths and limitations as behavioral therapy platforms for pharmacotherapy trials and as potential concomitant therapies in clinical practice.

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

“…There is consensus in the scientific community that combining behavioral treatments and pharmacological agents provides more effective treatment than either constituent therapy alone in most cases (Carroll et al, 2004b;Onken et al, 1995;Stitzer and Walsh, 1997;Volkow et al, 2004). Carroll (Carroll et al, 2004b) however, specifically stated that determinations of optimal behavioral therapy platform-pharmacotherapy combinations should be evidence based, not arbitrarily determined.…”

“…Support for CBT in the treatment of cocaine dependence has been demonstrated (Carroll et al, 1991(Carroll et al, , 1994Maude-Griffin et al, 1998;McKay et al, 1997;Rohsenow et al, 2000;Schmitz et al, 1997), with recent evidence suggesting additive effects when combining CBT with pharmacotherapy (Carroll et al, 2004a;Carroll et al, 1998;Schmitz et al, 2001). CBT is considered to be more powerful than ClinMan, but not sufficiently potent to override medication effects (Carroll et al, 2004b).…”

“…Whereas abstinence or reduced substance use is the target for all these platforms, specific therapies differ in intensity and potency (Carroll et al, 2004b). More intense therapies have been recommended for medications having weak or partial effects, so that continued heavy drug use does not override potential pharmacotherapy effects (Carroll et al, 2004b).…”

“…Whereas abstinence or reduced substance use is the target for all these platforms, specific therapies differ in intensity and potency (Carroll et al, 2004b). More intense therapies have been recommended for medications having weak or partial effects, so that continued heavy drug use does not override potential pharmacotherapy effects (Carroll et al, 2004b). Still, in the conduct of clinical trials, Carroll and colleagues describe the need to strike a balance between reducing substance use with behavioral treatments while avoiding ceiling effects that might obscure or prohibit detection of medication effects.…”

Behavioral Therapies Trials

“…Behavioral therapy platforms, used alone or in combination, are required to support pharmacotherapy trials for substance use (Carroll, Kosten, & Rounsaville, 2004). The primary purpose of this report is to describe the stage model as a method for behavioral therapies research, focusing on the critical first stage, therapy development.…”