Posttraumatic Stress Disorder Clinical Trial
Official title:
A Placebo-Controlled Trial of Prazosin in Individuals With Co-occurring Alcohol Dependence and PTSD Seeking Abstinence
The purpose of this study is to determine whether the drug prazosin is effective for the treatment of alcohol dependency and symptoms of Posttraumatic Stress Disorder (PTSD).
Background: Alcohol dependence (AD) is a biologically, genetically based disease, yet the
majority of clinically accepted treatments are behaviorally or psychosocially based. PTSD and
alcohol use disorders (AUDs) commonly co-occur. This comorbidity is associated with more
severe clinical impairment, shorter times to relapse, more treatment recidivism, overall
greater use of treatment services, and greater treatment costs.
Neuropharmacology of alcohol and prazosin: Emerging pre-clinical evidence shows that
noradrenergic systems are involved in brain processes relevant to AD, such as arousal,
reinforcement, and stress responsivity. However, virtually no work to date has attempted to
translate this knowledge into clinically effective biological interventions. The
investigators have adopted the novel, promising strategy of reducing adrenergic activity by
blocking noradrenaline binding to post-synaptic alpha-1 receptors via the non-selective,
alpha-1 antagonist, prazosin. Preclinical studies have demonstrated that prazosin decreases
reinstatement of alcohol consumption, and preliminary clinical data suggest that prazosin
reduces alcohol use in humans with AD and reduces PTSD-related nightmares and other symptoms,
though it has not been tested in individuals with comorbid AD and PTSD. Prazosin, FDA
approved to treat hypertension, typically has few side effects, and is inexpensive.
Design: Randomized double-blind placebo-controlled clinical trial. Participants: 60
individuals with both AD and PTSD (25% women) with stated goal to abstain from alcohol use.
Intervention: Either prazosin titrated per study protocol or matched placebo for 6 weeks with
Medical Management (MM) based on the COMBINE Study procedures and a final study visit two
weeks after medication discontinuation.
Measures: The primary outcomes are alcohol use during the 12-week medication phase of the
study and reports of craving during the same time period. Daily, prompted Interactive Voice
Response (IVR) telephone monitoring will be done throughout the 8-week study to assess the
primary outcomes and to provide information on affect and medication adherence. Such daily
monitoring provides more accurate reports of alcohol use than standard retrospective outcome
measures. Analyses: Hierarchical linear modeling to test for main effects of prazosin+MM
versus placebo+MM on alcohol use and PTSD symptoms over time, and to evaluate whether
reductions in PTSD mediate the effect of prazosin.
Findings to date: Participants randomized to prazosin had a greater reduction in percent days
drinking per week and percent days heavy drinking per week between baseline and week 6 than
did placebo participants. No significant differences were detected within or between groups
in change from weeks 1 to 6 in total PTSD symptoms. Participants in the prazosin condition
reported drowsiness on significantly more days than those in the placebo condition. Public
health implications: There is a paucity of safe, tolerable, inexpensive, and efficacious
drugs currently available for the treatment of AD and PTSD. Consistent with the extant
research evaluating medications for comorbid PTSD/AD, the current evaluation of prazosin also
found decreased alcohol consumption but no medication effect on PTSD symptomatology.
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