Differences between treatment-seeking and non-treatment-seeking participants in medication studies for alcoholism: do they matter?

Abstract

Background: Medication development for alcoholism typically includes experimental pharmacology studies with non-treatment seeking individuals with alcohol use disorder (AUD) paving the way for randomized controlled trials in treatment-seekers with AUD. Objectives: The goal of this study is to provide a direct comparison between AUD treatment-seeking research participants and non-treatment seeking participants on demographic and clinical variables and to test whether variables that differentiate the two groups are associated with clinical outcomes. Method: Non-treatment seeking AUD participants (n=213; 76.3% male) who completed behavioral pharmacology studies were compared to treatment-seekers who completed the COMBINE Study (n=1383; 69.1% male) on demographic and clinical variables. Analyses examined whether the variables that differentiated the two groups predicted treatment outcomes in the COMBINE Study. Results: Analyses revealed that treatment seeking participants were older, had more years of education, higher Alcohol Dependence Scale scores, higher Drinker Inventory of Consequences scores, higher Obsessive Compulsive Drinking Scale scores, greater number of DSM-IV symptoms of AUD, longer duration of AUD and consumed more standard drinks and more drinks per drinking day (i.e., in past 30 days) compared to non-treatment seeking participants. Nearly all characteristics that differed between the groups predicted at least one of the primary clinical outcomes of the COMBINE Study. Conclusions: This study highlights a host of clinical and demographic factors that differ between non-treatment seeking and treatment seeking research participants and the clinical significance of these variables. Differences between samples should be considered and addressed in order to promote greater consilience across stages of medication development.

Differences in Sociodemographic and Alcohol‐Related Clinical Characteristics Between Treatment Seekers and Nontreatment Seekers and Their Role in Predicting Outcomes in the COMBINE Study for Alcohol Use Disorder

“…Another aim of our study was to test whether the characteristics that differed significantly between the Brown nontreatment seekers and the COMBINE treatment seekers predicted any of the 3 main COMBINE study clinical outcomes, that is, time to relapse, PDA, and GCO. Other studies have found that specific participant characteristics are moderators or predictors of treatment outcomes in the COMBINE study (Gueorguieva et al, 2015;Ray et al, 2017;Subbaraman et al, 2013;Worley et al, 2015). In particular, the UCLA work (Ray et al, 2017) found that nearly all the sociodemographic and clinical characteristics differing significantly between the UCLA nontreatment seekers and the COMBINE treatment seekers predicted at least 1 COM-BINE study outcome.…”

“…In the clinical research setting, participants are often selected based on their treatment-seeking status (nontreatment seekers and treatment seekers) for methodological and ethical reasons, particularly when human laboratory studies include the administration of alcohol (Enoch et al, 2009). However, differences have been found between nontreatment and treatment seekers across sociodemographic characteristics, such as sex, age, level of education, employment, and marital status (Lee et al, 2019;Locastro et al, 2008;Ray et al, 2017;Rohn et al, 2017). These populations have also been found to differ in alcohol-related clinical characteristics, such as age of onset and duration of AUD, or number of drinks consumed per day (Ray et al, 2017).…”

“…However, differences have been found between nontreatment and treatment seekers across sociodemographic characteristics, such as sex, age, level of education, employment, and marital status (Lee et al, 2019;Locastro et al, 2008;Ray et al, 2017;Rohn et al, 2017). These populations have also been found to differ in alcohol-related clinical characteristics, such as age of onset and duration of AUD, or number of drinks consumed per day (Ray et al, 2017). They may also differ in characteristics that go beyond the quantity of alcohol consumption, such as history of trauma, personality traits, impulsivity, aggressive behavior, cognition, mood, and liver enzyme levels, which are generally associated with excessive alcohol use (Rohn et al, 2017).…”

Screening and care for alcohol use disorder in France: expectations, barriers and levers using a mixed-methods approach

“…There are many possible explanations for the association between older age and seeking AUD treatment. Older people are more likely to have a longer alcohol history, and therefore are more likely to seek treatment [46]. There are also metabolic reasons which make alcohol use more dangerous for older patients [47] and could constitute a motivation to change one's level of alcohol consumption.…”

Dopaminergic Genetic Variation Influences Aripiprazole Effects on Alcohol Self-Administration and the Neural Response to Alcohol Cues in a Randomized Trial

“…The upper age limit was chosen for two reasons. First, the study required alcohol administration; this can only be ethically achieved on an outpatient basis among non-treatment-seeking subjects, who tend to be younger than treatment seekers (Ray et al, 2017). Second, subjects were randomized to medication on the basis of a trait impulsivity measure (see below); as age and impulsivity are negatively correlated (Galvan et al, 2007), the upper limit was intended to ensure a sufficient number of individuals with higher impulsivity.…”