The potential impact of recruitment method on sample characteristics and treatment outcomes in a psychosocial trial for women with co-occurring substance use disorder and PTSD

Abstract

Background Recruitment method can impact the sample composition of a clinical trial and, thus, the generalizability of the results, but the importance of recruitment method in substance use disorder trials has received little attention. The present paper sought to address this research gap by evaluating the association between recruitment method and sample characteristics and treatment outcomes in a substance use disorder trial. Method In a multi-site trial evaluating Seeking Safety (SS), relative to Women’s Health Education (WHE), for women with co-occurring PTSD (either sub-threshold or full PTSD) and substance use disorders, one site assessed the method by which each participant was recruited. Data from this site (n=106), which recruited participants from newspaper advertising and clinic intakes, were analyzed. Results Participants recruited through advertising, relative to those from the clinic, had significantly higher levels of baseline drug use and higher rates of meeting DSM-IV-TR criteria for full PTSD. Results suggest that the effectiveness of SS in decreasing PTSD symptoms was greater for participants recruited through advertising relative to those recruited from the clinic. Conversely, the results revealed a significant treatment effect in the clinic-recruited participants, not seen in the advertising-recruited participants, with SS, relative to WHE, participants being more likely to report past week drug use during the follow-up phase. Conclusion Recruitment method may impact sample composition and treatment effects. Replication of this finding would have important implications for substance use disorder efficacy trials which often utilize advertising to recruit participants.

Mortality Rates Among Substance Use Disorder Participants in Clinical Trials: Pooled Analysis of Twenty-Two Clinical Trials Within the National Drug Abuse Treatment Clinical Trials Network

“…As individual SUD clinical trials are too short and small to yield stable estimates, pooling participants across trials creates more stable estimates. Similarities in the CTN participant characteristics population provide a rationale for pooling across trial, such as socioeconomic status, racial and ethnic groups, employment status, and educational level (Calsyn et al, 2009; Campbell et al, 2010; Carroll et al, 2006; Donovan et al, 2013; Hien et al, 2010; Hien et al, 2009; Horigian, Robbins, Dominguez, Ucha, & Rosa, 2010; Korthuis et al, 2012; Kropp et al, 2013; Masson et al, 2013; Meade et al, 2010; Svikis et al, 2012; Weiss et al, 2011; Winhusen, Winstanley, Somoza, & Brigham, 2012; Woody et al, 2008). Participants were typically recruited from community-based substance abuse treatment programs (CTPs) within the CTN network (McCarty et al, 2008) and trials were designed by NIDA CTN investigators with common goals of bridging practice with substance abuse treatment research results (Tai et al, 2010; Wells, Saxon, Calsyn, Jackson, & Donovan, 2010b).…”

Multisite, Randomized, Double-Blind, Placebo-Controlled Pilot Clinical Trial to Evaluate the Efficacy of Buspirone as a Relapse-Prevention Treatment for Cocaine Dependence

“…Another study strength is that it was conducted with individuals seeking treatment at SUD treatment programs and, thus, the results are likely generalizable to individuals in treatment for stimulant-dependence disorders. 30 Other strengths include the very high retention and good medication adherence rates. The small sample size of the present trial is a significant limitation in that small trials do not provide accurate estimates of treatment effect, 31 nor was this study adequately powered to detect differences in efficacy outcomes since the primary goal of this study was to address important operational aspects that would be applied to a second, larger trial.…”

A Randomized Trial of Concurrent Smoking-Cessation and Substance Use Disorder Treatment in Stimulant-Dependent Smokers

“…Another study strength is that it was conducted with individuals seeking treatment at SUD treatment programs and, thus, the results are likely generalizable to individuals in treatment for stimulant-dependence disorders. 34 Other strengths include the high retention rate and strong adherence with smoking cessation counseling and taking bupropion as prescribed. Thus, while adherence with the nicotine inhaler was poor, the TAU+SCT participants received important elements of effective smoking-cessation treatment.…”