At a glance
ClinicalIndex Comparison Record- ✓Current DSM-5 diagnosis of PTSD
- ✓Current DSM-5 diagnosis of moderate or greater severity AUD (≥4 criteria endorsed in last 3 months)
- ✓Heavy alcohol use: ≥21 units/week for women or ≥28 units/week for men in the last 30 days, sustained 7 days prior to randomization
- ✓Age 18–65 years, weighing 40–155 kg (within 30% of ideal body weight per Metropolitan Life Tables)
- ✕Any current DSM-5 psychiatric disorder other than PTSD, AUD, or Tobacco Use Disorder that warrants treatment
- ✕Severe alcohol withdrawal symptoms requiring inpatient treatment per physician judgment
- ✕Inpatient or outpatient alcohol dependence treatment within the last 30 days
- ✕Concurrent use of medications affecting alcohol consumption, mood, or related behaviors (opioid antagonists, glutamate antagonists, SSRIs, serotonin antagonists, antidepressants, dopamine antagonists, calcium channel antagonists, disulfiram-like compounds, nicotine)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pharmacogenetic Treatment With Anti-Glutaminergic Agents for Comorbid PTSD & AUD
In Brief
A Phase 3 clinical trial evaluating Pregabalin plus BBCET and Placebo plus BBCET for PTSD and Alcohol Use Disorder. Completed, enrolled 57 participants across 1 site.
Detailed Summary
The primary study objective is to determine the efficacy of pregabalin administered orally for a period of 12 weeks in reducing risky drinking and symptoms of posttraumatic stress disorder who have selected genotypes at the gamma-amino butyric acid transporter and receptor genes. The secondary objective is to assess the safety and tolerability of pregabalin in participants with alcohol use disorder and co-occurring posttraumatic stress disorder who have selected genotypes at the gamma-amino butyric acid transporter and receptor genes. The investigators will utilize a sample of African-Americans that includes both genders and individuals with different types of trauma.
Study Details
Timeline
Interventions
Medication; BBCET = Brief Behavioral Compliance Enhancement Treatment
Placebo; BBCET = Brief Behavioral Compliance Enhancement Treatment