Single versus multiple drug focus in substance abuse clinical trials research

Abstract

Complex patterns of multiple substance use pose clinical and methodological challenges for substance abuse clinical trials research. To increase measurement precision and internal validity, the modal approach has been to target both treatment interventions and outcome assessment to a single class of abused substance. This strategy warrants reconsideration because it entails limitations in recruitment feasibility and generalization of study findings. This report reviews pros and cons of single versus multiple targeted drugs, suggests guidelines for choosing between these strategies and outlines methods for broadening the scope of substance abuse clinical trails to take abuse of multiple substances into account. We recommend that investigators consider moving away from a single drug focus in three ways. First, include systematic assessment of a wide range of psychoactive substance use throughout the trial and evaluate the impact of study treatments on use of all classes of drugs. Second, except where contraindicated, include patients who use and abuse multiple classes of substances even in trials evaluating treatment of a single targeted drug. Third, consider inclusion of polysubstance abusers or those who primarily abuse multiple classes of substances in the same clinical trial. Although many treatment efficacy questions can best be answered by single focus studies, we recommend that such designs be adopted only after less restrictive designs are first considered.

Affective Decision-Making Is Predictive of Three-Month Relapse in Polysubstance-Dependent Alcoholics

“…The main strength of the study is that it used a large sample representative of current real-world clinical populations [52]. This implies that the present findings can not only be used easily in clinical practice, but they can also be generalized to an important number of substance-dependent patients in need of effective treatments [20,21].…”

Subtyping of substance use disorders in a high-risk welfare-to-work sample: A latent class analysis

“…These individuals are more likely to have had multiple treatment admissions as compared to those with abuse or dependence of only one drug class (Office of Applied Studies, 2005). Epidemiologic and treatment outcome studies typically focus on only one class of drug abuse/dependence despite the fact that most patients with substance use disorders (SUDs) have abused more than one substance (Brecht, Huang, Evans, & Yih-Ing, 2008;Rounsaville, Petry, & Carroll, 2003). Those studies that have focused on polysubstance use disorders typically consider individuals with polysubstance abuse/dependence as a homogeneous category, when there may be a great deal of heterogeneity among individuals who abuse multiple substances (Conway, Kane, Ball, Poling, & Rounsaville, 2003;Kedia, Sell, & Relyea, 2007).…”

The Effectiveness of Telephone-Based Continuing Care for Alcohol and Cocaine Dependence

“…Finally, the participants were typical of patients in publicly funded, outpatient substance abuse treatment programs. 52,53 With regard to limitations, it is important to stress that the results of the study do not in any way suggest that telephone-based interventions will be more effective as an initial approach to the treatment of substance dependence than intensive outpatient treatment, relapse prevention, or group counseling. In that regard, cognitivebehavioral treatments have demonstrated efficacy as an initial treatment in numerous studies, 20,[22][23][24] although there are some studies that find no difference between cognitivebehavioral treatments and other active treatments.…”