Do clinical trials of treatment of alcohol dependence adequately enroll participants with co-occurring independent mood and anxiety disorders? An analysis of data from the National Epidemiologic Survey on Alcohol and Related Conditions (NESARC).

BACKGROUND

In the care of alcohol-dependent patients, co-occurring independent (ie, not substance-induced) mood and anxiety disorders present a significant challenge. Clinical trials of alcohol dependence treatment could help clinicians meet this challenge, but only if they enroll such complex patients. This study examined whether such individuals are likely to be included in alcohol dependence treatment trials under typical eligibility criteria.

METHOD

Data were derived from the 2001-2002 National Epidemiologic Survey on Alcohol and Related Conditions (NESARC), a national representative sample of 43,093 adults in the United States population. Psychiatric diagnoses were made according to the DSM-IV criteria with the Alcohol Use Disorder and Associated Disabilities Interview Schedule-DSM-IV Version (AUDADIS-IV).

RESULTS

Of 1,484 alcohol-dependent participants, 39.22% (SE = 1.67) had a co-occurring independent mood or anxiety disorder; more than 60% of these individuals would be ineligible for an alcohol dependence treatment trial under typical eligibility criteria. Alcohol-dependent individuals with current major depressive episode, mania, dysthymia, panic disorder, and generalized anxiety disorder were particularly likely to be excluded from clinical trials. In a subsample of 185 individuals who had sought alcohol treatment, 52.59% (SE = 4.42) had an independent mood or anxiety disorder. Remarkably, almost all of these individuals (96.93%, SE = 1.97) would have been ineligible for clinical trials.

CONCLUSIONS

Independent mood and anxiety disorders are prevalent in the alcohol-dependent population but not in clinical trial research samples. For alcohol dependence treatment trials to adequately inform clinical practice, the enrollment of patients with co-occurring mood or anxiety disorders must be increased, through trials tailored to this population, a general relaxation of overly stringent eligibility criteria, or both.