A Phase 2 interventional study of Zonisamide and Placebo Comparator in Post Traumatic Stress Disorder and Alcohol Use Disorder, sponsored by Pharmacotherapies for Alcohol and Substance Use Disorders Alliance. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2021-03-09.
Sponsored by Pharmacotherapies for Alcohol and Substance Use Disorders Alliance · Phase 2, Interventional, and Treatment
The objective of this study is to determine if, compared to placebo, zonisamide (400mg/day) is a safe and efficacious treatment for post-traumatic stress disorder (PTSD) and alcohol use disorder (AUD) in Veterans with PTSD and co-occurring AUD.
This is a randomized, double-blind, placebo-controlled study to examine the ability of 5-weeks treatment with zonisamide to reduce symptoms of PTSD and AUD. The study population will consist of 60 Veterans with combat-related PTSD and co-morbid AUD. Veterans will be randomized 1:1 to receive either zonisamide (up to 400 mg/day) or placebo daily for 35±4days, followed by a 14-day down-titration period with follow-up. Primary efficacy variables are scores on the CAPS-5, fear-potentiated startle (FPS) responses, and percent of heavy drinking days (%HDD).
2,682 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 601 are open to participants now.
Browse Stress Disorders, Post-Traumatic studies →Pharmacotherapies for Alcohol and Substance Use Disorders Alliance is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Be taking blood pressure medications, psychotropics (with exception of SSRIs/SNRIs), drugs effecting the CNS, medications with ethanol, any sulfonamide, or any other medication that could interact with study medications or alter the effects of alcohol.
a. Note that participants may currently be seeking treatment (or already receiving a behavioral treatment) for AUD, but may not be taking medications used in the treatment of AUD (acamprosate, disulfiram, oral naltrexone, and extended-release injectable naltrexone, and topiramate)
Have neurological or psychiatric disorders other than PTSD or AUD (except mild/moderate depression succeeding PTSD). Examples include:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Zonisamide capsules titrated to a maximum tolerated dose of 400 mg/day for 35 days +/- 4 days, followed by a 14 day down-titration period.
Drug: Zonisamide
Encapsulated placebo filler (lactose) for 35 +/- 4 days, followed by a 14 day down-titration period. Placebo will go through a similar perceived titration process to maintain blind.
Drug: Placebo Comparator
Zonisamide capsules titrated to a maximum tolerated dose of 400 mg/day for 35 days +/- 4 days, followed by a 14 day down-titration period.
Encapsulated placebo filler (lactose) for 35 +/- 4 days, followed by a 14 day down-titration period. Placebo will go through a similar perceived titration process to maintain blind.
Change from baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total symptom severity score
CAPS-5 is a 30-item questionnaire, corresponding to the DSM-5 diagnosis for PTSD. All symptoms are assessed on a five-point scale (0=Absent, 1=Mild/subthreshold, 2=Moderate/threshold, 3=Severe/markedly elevated, 4=Extreme/incapacitating). CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms, possible scores ranging from 0-80 with higher values indicating a worse symptom severity.
Time frame: Baseline to post-treatment (weeks 0, 3, 5, 7)
Percent change in fear-potentiated startle (FPS) responses from acquisition on day 1 to recall on day 35.
Time frame: Baseline to post-treatment (weeks 1, 5, 7)
Change from baseline in the percent of heavy drinking days (%HDD)
Timeline Follow-Back (TLFB) of self-report assessment of heavy drinking days over the course of the five-week study treatment.
Time frame: Baseline to post-treatment (weeks 0-7)
Severity and numbers of AEs
All safety analyses will be performed using the safety population (i.e., as treated) unless otherwise specified. Rates, severity and relatedness of adverse events including serious adverse events, study drug-related adverse events, and deaths will be evaluated.
Time frame: Baseline to post-treatment (weeks 0-7)
Treatment retention
Retention will be assessed as a comparison count of participants at baseline and post-treatment.
Time frame: Baseline to post-treatment (weeks 0-5)
Medication compliance
We will use self-report and pill count. Overall percentage of pills taken will be calculated and reported.
Time frame: Baseline to post-treatment (weeks 0-5)
Medication adherence
To assess medication adherence, urine samples collected at study visits will be tested for riboflavin, using a quantitative assessment of fluorescence. Results will be summarized over time for the active treatment study group.
Time frame: Baseline to post-treatment (weeks 0-5)
Blood pressure
Systolic and diastolic blood pressure results will be summarized over the time of the study.
Time frame: Baseline to post-treatment (weeks 0-7)
Heart rate
Heart beats per minute will be summarized over the time of the study.
Time frame: Baseline to post-treatment (weeks 0-7)
ECG abnormalities
Frequency of ECG Summary results (i.e. Normal, Abnormal but clinically insignificant, or Abnormal and clinically significant) will be summarized over the time of the study.
Time frame: Baseline to post-treatment (weeks 0-7)
Breath alcohol content (BAC)
BAC as measured by an alcohol breathalyzer test, lower percentages indicating less alcohol breath content.
Time frame: Baseline to post-treatment (weeks 0-7)
Subjective and psychometric effects of alcohol (e.g. mood, urge/craving)
Alcohol Urge Questionnaire (AUQ) scores will be calculated, with higher scores reflecting higher craving.
Time frame: Baseline to post-treatment (weeks 0-7)
Alcohol use measures
Drinks per day including days abstained from drinking will be evaluated.
Time frame: Baseline to post-treatment (weeks 1, 3, 7)
Presence and symptom assessments for PTSD
PTSD Checklist for DSM-5 (PCL-5) scores will be calculated, with higher scores reflecting higher severity.
Time frame: Baseline to post-treatment (weeks 0-7)
Change from baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) subscale scores: Criterion B (reexperiencing)
CAPS-5 is a 30-item questionnaire, corresponding to the DSM-5 diagnosis for PTSD. All symptoms are assessed on a five-point scale (0=Absent, 1=Mild/subthreshold, 2=Moderate/threshold, 3=Severe/markedly elevated, 4=Extreme/incapacitating). Criterion B is the sum of items 1-5 (scores range 0-20). A higher score indicates worse symptom severity.
Time frame: Baseline to post-treatment (Weeks 0, 3, 5, 7)
Change from baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) subscale scores: Criterion C (Avoidance)
CAPS-5 is a 30-item questionnaire, corresponding to the DSM-5 diagnosis for PTSD. All symptoms are assessed on a five-point scale (0=Absent, 1=Mild/subthreshold, 2=Moderate/threshold, 3=Severe/markedly elevated, 4=Extreme/incapacitating). Criterion C is the sum of items 6 and 7 (scores range 0-8). A higher score indicates worse symptom severity.
Time frame: Baseline to post-treatment (Weeks 0, 3, 5, 7)
Change from baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) subscale scores: Criterion D (negative alterations in cognitions and mood)
CAPS-5 is a 30-item questionnaire, corresponding to the DSM-5 diagnosis for PTSD. All symptoms are assessed on a five-point scale (0=Absent, 1=Mild/subthreshold, 2=Moderate/threshold, 3=Severe/markedly elevated, 4=Extreme/incapacitating). Criterion D is the sum of items 8-14 (scores range 0-28). A higher score indicates worse symptom severity.
Time frame: Baseline to post-treatment (Weeks 0, 3, 5, 7)
Change from baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) subscale scores: Criterion E (hyperarousal)
CAPS-5 is a 30-item questionnaire, corresponding to the DSM-5 diagnosis for PTSD. All symptoms are assessed on a five-point scale (0=Absent, 1=Mild/subthreshold, 2=Moderate/threshold, 3=Severe/markedly elevated, 4=Extreme/incapacitating). Criterion E is the sum of items 15-20 (scores range 0-24). A higher score indicates worse symptom severity.
Time frame: Baseline to post-treatment (Weeks 0, 3, 5, 7)
Plan to share: Yes — CDMRP has a policy to share and make available to the public the results and accomplishments of the activities that it funds. The PASA consortium plans to share de-identified data after final publication in a government-supported data repository.
Start is estimated for Mar 2019.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Zonisamide
Stress Disorders, Post-Traumatic →
Pharmacotherapies for Alcohol and Substance Use Disorders Alliance