RECRUITING

Leveraging Biomarkers for Personalized Treatment of Alcohol Use Disorder Comorbid With PTSD

Conditions

Post Traumatic Stress Disorder Alcohol Use Disorder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a double-blind, 2-group randomized controlled trial evaluating the effects of topiramate versus placebo in patients with comorbid PTSD and moderate-to-severe AUD. This trial will provide one of the first rigorous tests of whether the effects of topiramate in AUD generalize to patients with co-occurring PTSD, and one of the first rigorous tests of whether topiramate has beneficial effects on PTSD symptoms in this population. It will be the first study to test whether the rs2832407 genotype predicts clinical response to topiramate for AUD and PTSD in patients with both disorders. Further, it will contribute to the understanding of topiramate's mechanisms of action in the co-morbid AUD/PTSD population, and to the discovery of predictors of treatment response.

Official Title

Leveraging Biomarkers for Personalized Treatment of Alcohol Use Disorder Comorbid With Post Traumatic Stress Disorder

Quick Facts

Study Start:2019-10-16

Study Completion:2025-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03667846

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Males and females aged 18-70 years old 2. DSM-5 diagnosis of moderate or severe AUD (using SCID5) 3. Endorse a desire to cut down or stop drinking 4. At least 4 heavy drinking days (4 or more drinks per day for a woman, 5 or more drinks per day for a man) in the 30 days prior to screen 5. DSM-5 current diagnosis of PTSD with the Clinician Administered PTSD Scale OR subPTSD diagnosis (meeting criterion A, F, G, H and at least 6 symptoms across any criteria B-E) with Clinician Administered PTSD Scale (CAPS-5) 6. If of childbearing potential (male or female), are willing to use contraception for duration of the trial 7. Able to provide at least 2 locators 8. Able to provide voluntary informed consent 9. Confirms they are reliably domiciled	1. Current alcohol withdrawal (CIWA-Ar score \>7) 2. DSM-5 diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder I, current significant suicidality (assessed using the C-SSRS), any significant suicidal behavior in the past 12 months, or any history of serious suicide attempts requiring hospitalization, or active homicidality 3. DSM-5 diagnosis of current severe substance use disorder for a substance other than alcohol or nicotine 4. Any history of severe traumatic brain injury (assessed using the OSU TBI-ID modified). If current (past 12 months) mild/moderate TBI and CSI score ≥12 (for either lifetime month or current month), the PI will determine eligibility. 5. Exposure to trauma in the last 30 days, including police duty or military service 6. Significantly impaired liver function defined as a) alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \> 5 x upper limit of normal (ULN); b) ALT or AST \> 3 x ULN with concomitant total bilirubin \> 2.0 x ULN; or c) ALT or AST ≥ 3 x ULN with the appearance of fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, and/or eosinophilia 7. Other medical conditions which would preclude safe participation in the study 8. Significant laboratory abnormalities, including significantly impaired hepatic function, abnormalities in complete blood count or metabolic panel 9. Current use of medications with the potential for adverse drug-drug interactions including but not limited to CNS depressants specified anticonvulsants (such as: Phenytoin, Carbamazepine and Depakote), metformin, and pharmacologic treatments for addictions including alcohol use disorder ,and other Carbonic Anhydrase inhibitors (i.e. zonisamide, acetazolamide, dichlorphenamide). Oral contraceptives are permitted as long as participants who are on an estrogen and/or estrogen-progesterone form use a double barrier contraceptive. Antidepressant medications are permitted if participants have been on a stable dose for at least 4 weeks prior to screening and the dose may not be changed during treatment phase (weeks 0-14) of the study. 10. Pregnancy or lactation 11. Current treatment for AUD (with the exception of AA/12-step treatment and/or psychosocial treatment initiated more than 2 months prior to the screening visit) 12. Current treatment for methadone or opioid abuse 13. Psychotherapy for PTSD or other psychiatric condition, if initiated within 3 months of screening 14. Allergy or hypersensitivity to topiramate 15. Active legal problems likely to result in incarceration within 12 weeks of treatment initiation 16. Significantly impaired renal function defined as) creatinine clearance rate \<70 mL/min/1.73 m2. 17. High risk of adverse emotional or behavioral reaction, and/or an inability to understand study procedures or the informed consent process, based on investigator's clinical evaluation (e.g., evidence of serious personality disorder, antisocial behavior, serious current stressors, lack of meaningful social support) 18. Inpatient psychiatric treatment in the last 12 months, with the exception of detox and extended Emergency Department stays

Inclusion Criteria

Exclusion Criteria

1. Males and females aged 18-70 years old
2. DSM-5 diagnosis of moderate or severe AUD (using SCID5)
3. Endorse a desire to cut down or stop drinking
4. At least 4 heavy drinking days (4 or more drinks per day for a woman, 5 or more drinks per day for a man) in the 30 days prior to screen
5. DSM-5 current diagnosis of PTSD with the Clinician Administered PTSD Scale OR subPTSD diagnosis (meeting criterion A, F, G, H and at least 6 symptoms across any criteria B-E) with Clinician Administered PTSD Scale (CAPS-5)
6. If of childbearing potential (male or female), are willing to use contraception for duration of the trial
7. Able to provide at least 2 locators
8. Able to provide voluntary informed consent
9. Confirms they are reliably domiciled

1. Current alcohol withdrawal (CIWA-Ar score \>7)
2. DSM-5 diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder I, current significant suicidality (assessed using the C-SSRS), any significant suicidal behavior in the past 12 months, or any history of serious suicide attempts requiring hospitalization, or active homicidality
3. DSM-5 diagnosis of current severe substance use disorder for a substance other than alcohol or nicotine
4. Any history of severe traumatic brain injury (assessed using the OSU TBI-ID modified). If current (past 12 months) mild/moderate TBI and CSI score ≥12 (for either lifetime month or current month), the PI will determine eligibility.
5. Exposure to trauma in the last 30 days, including police duty or military service
6. Significantly impaired liver function defined as a) alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \> 5 x upper limit of normal (ULN); b) ALT or AST \> 3 x ULN with concomitant total bilirubin \> 2.0 x ULN; or c) ALT or AST ≥ 3 x ULN with the appearance of fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, and/or eosinophilia
7. Other medical conditions which would preclude safe participation in the study
8. Significant laboratory abnormalities, including significantly impaired hepatic function, abnormalities in complete blood count or metabolic panel
9. Current use of medications with the potential for adverse drug-drug interactions including but not limited to CNS depressants specified anticonvulsants (such as: Phenytoin, Carbamazepine and Depakote), metformin, and pharmacologic treatments for addictions including alcohol use disorder ,and other Carbonic Anhydrase inhibitors (i.e. zonisamide, acetazolamide, dichlorphenamide). Oral contraceptives are permitted as long as participants who are on an estrogen and/or estrogen-progesterone form use a double barrier contraceptive. Antidepressant medications are permitted if participants have been on a stable dose for at least 4 weeks prior to screening and the dose may not be changed during treatment phase (weeks 0-14) of the study.
10. Pregnancy or lactation
11. Current treatment for AUD (with the exception of AA/12-step treatment and/or psychosocial treatment initiated more than 2 months prior to the screening visit)
12. Current treatment for methadone or opioid abuse
13. Psychotherapy for PTSD or other psychiatric condition, if initiated within 3 months of screening
14. Allergy or hypersensitivity to topiramate
15. Active legal problems likely to result in incarceration within 12 weeks of treatment initiation
16. Significantly impaired renal function defined as) creatinine clearance rate \<70 mL/min/1.73 m2.
17. High risk of adverse emotional or behavioral reaction, and/or an inability to understand study procedures or the informed consent process, based on investigator's clinical evaluation (e.g., evidence of serious personality disorder, antisocial behavior, serious current stressors, lack of meaningful social support)
18. Inpatient psychiatric treatment in the last 12 months, with the exception of detox and extended Emergency Department stays

Contacts and Locations

Study Contact

Dayeon Cho

CONTACT

646-754-7454

Dayeon.Cho@nyulangone.org

Michael Bogenschutz, MD

CONTACT

(646) 501-4026

Michael.Bogenschutz@nyulangone.org

Principal Investigator

Charles Marmar, MD

PRINCIPAL_INVESTIGATOR

NYU Langone Health

Study Locations (Sites)

New York University School of Medicine

New York, New York, 10016

United States

Collaborators and Investigators

Sponsor: NYU Langone Health

Charles Marmar, MD, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-10-16

Study Completion Date2025-08-31

Study Record Updates

Study Start Date2019-10-16

Study Completion Date2025-08-31

Terms related to this study

Additional Relevant MeSH Terms

Post Traumatic Stress Disorder
Alcohol Use Disorder