Summary

for people ages 18 years and up (full criteria)
at San Diego, California
study started
estimated completion:
Sonya B. Norman

Description

Summary

Alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD) frequently co-occur, and having both disorders is associated with greater psychological and functional impairment than having either disorder alone. The most effective PTSD treatment, prolonged exposure (PE) is sometimes less effective when individuals also have AUD. Anti-relapse medication appears promising to improve the effectiveness of PE to help individuals reduce alcohol use and PTSD symptoms and improve functioning. This study compares PE with and without topiramate, a medication shown to both reduce drinking and PTSD symptoms, with the hypothesis that combined PE and topiramate will be more effective than PE and placebo. The aim of this grant is to improve treatment outcomes for Veterans with AUD and PTSD.

Official Title

Combining Topiramate and Prolonged Exposure for PTSD and Alcohol Use Disorder

Details

Objectives. Alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD) frequently co-occur, and having one condition worsens the course of the other. Individuals with both disorders exhibit worse functioning across a number of domains than individuals with either disorder alone. Prolonged exposure therapy (PE) is among the most effective treatments for PTSD. PE has been rated as a frontline treatment by multiple guidelines and reviews including the VA/DoD Clinical Practice Guidelines for the treatment of PTSD. However, in studies of individuals with PTSD and AUD, changes in alcohol use are only slightly better than in control or standard care conditions, reductions in PTSD symptoms are sometimes modest relative to studies of PE in PTSD patients without AUD, and rates of drop out from treatment are high. Combining PE with medication to curb drinking shows promise to improve upon the effectiveness of PE for individuals with comorbid AUD and PTSD, although thus far few studies have examined combining psychotherapy and medication. Topiramate is the single medication that has shown effectiveness for both AUD and PTSD and shows promise for reducing drinking among individuals with AUD and PTSD. However, the effect of adding topiramate to PE to treat comorbid AUD/PTSD has yet to be examined. The critical next step is to test a best practice PTSD treatment, PE, together with a promising pharmacological agent, topiramate, which has been found to be effective for both AUD and PTSD. Innovation: This application seeks to shift current clinical practice paradigms. A refinement to existing interventions is proposed through integration of two evidence based treatments.

Methodology. The investigators propose to use a randomized, controlled, double blind study design to examine the effect of adding topiramate (TOP) to a best practice treatment for PTSD, PE. Participants will be 120 male and female Veterans from all services with AUD and PTSD. The investigators' primary aims are to determine the relative efficacy of PE+topiramate, as compared to PE+placebo, in reducing problematic drinking, reducing PTSD symptoms, and improving functioning and quality of life among Veterans with comorbid AUD/PTSD at post-treatment and 3- and 6-month post-treatment follow-up. The investigators will explore the extent to which decreases in drinking and PTSD symptoms lead to improvement in functioning.

The proposed study has the potential to improve functional and psychological recovery for a highly prevalent and highly impaired population of Veterans. This study will test a novel and innovative combination of psychotherapy and medication with the goal of improving the care of Veterans. The successful completion of this project will help change the practices that drive treatment for Veterans who have both AUD and PTSD. The fundamental rationale for this study is to improve the evidence base that informs how patients with AUD and PTSD can attain sustained recovery from both of these disorders. The investigators will also explore whether changes in PTSD symptoms in the PE+TOP condition are partially explained by reductions in alcohol cravings.

Keywords

PTSD and Alcohol Use Disorder PTSD alcohol use disorder Veterans Alcohol Drinking Topiramate prolonged exposure prolonged exposure + topiramate

Eligibility

You can join if…

Open to people ages 18 years and up

  • Veteran of the U.S. military or and Reserve/National Guard member
  • are at least 18 years of age
  • have a BMI 18 kg/m2
  • are survivors of a psychological trauma meeting DSM-5 criterion A, at least one month post-trauma
  • have current DSM-5 diagnoses of AUD and PTSD based on semi-structured diagnostic interviews
  • have at least 20 days of heavy drinking (>= 5 drinks/day for men and >= 4/drinks per day for women) in the last 90 days spent in a non-restricted environment and meet criteria for heavy drinking at least 4 days in the 30 days prior to screening
  • are not currently receiving trauma-focused psychotherapy
  • are literate in English and intend to stay in the San Diego area during study participation
  • are willing to attend psychotherapy, medication, and assessment sessions
  • trying or planning to try to cut down on or abstain from alcohol
  • are generally in good health, as confirmed by medical history, physical examination,laboratory tests, and vital signs
  • for females of childbearing potential, agree to use an approved form of contraception for the duration of the study, including:
  • hormonal contraceptives (e.g., oral contraceptives or implantable devices)
  • intrauterine device (IUD)
  • or double barrier methods (e.g., diaphragm with spermicidal condom)
  • are capable of giving informed consent

You CAN'T join if...

  • based on medical history and physical examination conducted by the study physician,report or show evidence of a clinically significant medical condition including, but not limited to:
  • symptomatic coronary artery or peripheral vascular disease
  • malignancy or history of malignancy within the past 5 years (except basal cell carcinoma)
  • clinically significant renal disease and/or impaired renal function as defined by participants with an estimated creatinine clearance of 60 mL/min
  • clinically significant diseases of the gastrointestinal system including active liver disease
  • participants with AST and/or ALT >3 times the upper limit of the normal range and/or serum bilirubin >2 times the upper limit of normal at screening
  • Note: if these values are abnormal they can be retested prior to enrollment.If the repeat study is within the limits of the protocol, the participant may be randomized
  • pulmonary disorders including participants with active tuberculosis
  • endocrinological disorders
  • neurological disorders including participants with seizure disorders and participants with progressive and degenerative neurological disorders (e.g.,multiple sclerosis)
  • any disease or condition that compromises the function of those body systems that could result in altered absorption, excess accumulation or impaired metabolism or excretion of topiramate
  • participants with myocardial infarction, unstable angina, stroke or other major cardiovascular event within 6 months of the screening period
  • have been treated with topiramate for any reason in the past and discontinued the drug due to an adverse event or to a hypersensitivity reaction DSM-5 diagnosis of an uncontrolled psychiatric disorder with psychotic symptoms or cognitive impairment
  • in the opinion of the investigator, should not be enrolled because of the precautions,warnings, or contraindications listed on the topiramate package insert (e.g. history of kidney stones, glaucoma)
  • have a history of nephrolithiasis
  • are taking or plan to take during the study period prohibited medications including,but not limited to
  • other anti-relapse medications
  • stimulants
  • anxiolytics and sedative hypnotics
  • herbal preparations
  • other antiepileptic agents
  • antipsychotics
  • carbonic anhydrase inhibitors
  • systemic corticosteroids
  • or opioid analgesics.
  • These medications will be prohibited for a washout period of five serum half-lives
  • are pregnant, lactating, or plan to become pregnant during the period of participation in the study
  • in the judgment of the investigator, represent a significant risk of suicidal or homicidal behavior

Location

  • VA San Diego Healthcare System, San Diego, CA accepting new patients
    San Diego California 92161 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
VA Office of Research and Development
ID
NCT03176953
Phase
Phase 2/3
Lead Scientist
Sonya B. Norman
Study Type
Interventional
Last Updated
April 3, 2018