Post Traumatic Stress DisorderPhase 2NCT03376139
Zonisamide Outpatient Study
A Phase 2 study testing Zonisamide in people with Post Traumatic Stress Disorder and Alcohol Use Disorder, run by Pharmacotherapies for Alcohol and Substance Use Disorders Alliance at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Post Traumatic Stress Disorder, Alcohol Use Disorder
- What is being tested?
- Zonisamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2019to 31 Aug 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Be willing and able to sign and date an informed consent form
- Be a military service member or Veteran
- Male or female, 18-55 years of age
- Meet Diagnostic and Statistical Manual (DSM)-5 criteria for AUD
- Meet the DSM-5 diagnostic criteria for PTSD; PTSD diagnosis and severity will be determined based on CAPS-5 score greater than or equal to 33
- Self-report drinking heavily (5 standard units for males, 4 for females) on at least 30% of the 42 days prior to the screening interview
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- Score less than 10 on the revised clinical institute withdrawal assessment for alcohol scale (CIWA-Ar) assessed in the context of a breath alcohol concentration (BAC) less than or equal to 0.02% to demonstrate that they do not need medical detoxification (Sullivan et al. 1989)
- Have blood lab tests assessed at screening with ranges falling within the acceptable limits as noted in the protocol.
- Have normal vitals (heart rate 60-100 bpm, systolic blood pressure 90-140 mmHg and diastolic blood pressure 60-90 mmHg) and a baseline ECG that demonstrates clinically normal sinus rhythm, clinically normal conduction, normal QTc, and no clinically significant arrhythmias. Note that clinical judgement will be used when characterizing bradycardia among some healthy subject populations, for example, conditioned veterans. Thus, some individuals with bradycardia (i.e., heart rate less than 60 bpm) may be enrolled as determined by the admitting physician.
- Have a self-reported medical history and brief physical examination demonstrating no clinically significant contraindications for study participation, in the judgment of the admitting physician
- Psychotropic medication free (with exception of SSRIs/SNRIs) for 7 or more days (or longer, depending on medication half-life) prior to enrollment
- Be willing/able to stop use of any sleep medication for the duration of the study
- Be willing to comply with all study procedures and be available for the duration of the study
- Women must either be unable to conceive (i.e., surgically sterilized, sterile, or post-menopausal) or using double-mode form of contraception (i.e. barrier plus, e.g., birth control pills + intrauterine device, condoms + spermicide, etc.). Women can be receiving hormone replacement treatment (HRT) if the HRT dose has been stable for a period of at least 3 months
- Women must provide negative urine pregnancy tests prior to randomization
- Be willing to undergo a hearing test and be able to detect 500-2000 Hz tones at 40 dB or less.
Who cannot join
- DSM-5 criteria for substance use disorders other than alcohol or nicotine or test positive for prescription or illegal drugs. Regarding marijuana/THC, an individual must test negative at the screening. If an individual's test is positive, they will be given a grace period where they will have the opportunity to return and test negative prior to being enrolled.
- Be pregnant or nursing
- Be taking blood pressure medications, psychotropics (with exception of SSRIs/SNRIs), drugs effecting the CNS, medications contraindicated with ethanol, any sulfonamide, or any other medication that could interact with study medications or alter the effects of alcohol.
- 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:
- Current psychosis, bipolar illness or major depression requiring treatment.
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- Organic brain disease or dementia assessed clinical interview.
- History of any psychiatric disorder which would require ongoing treatment or which would make study compliance difficult.
- History of suicide attempts within the past year and/or current suicidal ideation/plan
- Have evidence of untreated or unstable medical illness including: cardiovascular, neuroendocrine, autoimmune, renal, hepatic, or active HIV+, AIDS infection.
- Have a history of medically adverse reactions to alcohol (e.g., loss of consciousness, chest pain, or epileptic seizure) or major alcohol-related medical complications requiring hospitalization (i.e. hepatitis or pancreatitis)
- Have contraindication(s) to take the study medications such as renal or hepatic impairment, congenital metabolic disorders, or hypersensitivity/allergies to study drug or similar compounds
- Have current epilepsy or evidence suggestive of seizure disorder
- Have past brain injury/head trauma with current symptoms (e.g. not photophobic, dizziness, etc.) or past report of loss of consciousness (LOC) for greater than 30 minutes and/or have been blast-exposed or had LOC of greater than 1 minute and current post-concussive symptoms
- Self-report more than thirty days abstinence from alcohol during the three months prior to enrollment/consent
- Current signs of violence or aggression, assessed as part of the consent process
- Participation in a pharmaceutical trial or exposure to any investigational drugs within 1 month of the screening visit
- Hearing loss that would interfere with the FPS measures
- Have any other illness, condition, or use medications (psychotropic or antiretroviral), which in the opinion of the PI and/or the admitting physician would preclude safe and/or successful completion of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Michael E. DeBakey Veterans Affairs Medical Center
Houston, Texas, 77030
About this study
Official title: Zonisamide as a New Treatment for Post-Traumatic Stress Disorder and Co-Occurring Alcohol Use Disorder
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.
Read the detailed description
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).
- Being tested
- Zonisamide, Placebo Comparator
- Keywords
- Alcohol, Alcoholic, Alcoholism, Alcohol abuse, Alcohol Use Disorder, Alcohol use, Alcohol dependence, Alcohol dependent, PTSD, Post-Traumatic Stress Disorder, Veteran
- Medical subject headings
- Stress Disorders, Post-Traumatic, Alcoholism, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZonisamideDrug
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.
Placebo ComparatorDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Zonisamide (up to 400 mg/day) | Experimental | 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. Receives: Drug: Zonisamide |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline to post-treatment (weeks 0-7)
Secondary outcomes (15)
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.
Measured: Baseline to post-treatment (weeks 0-7)
Treatment retention
Retention will be assessed as a comparison count of participants at baseline and post-treatment.
Measured: 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.
Measured: 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.
Measured: Baseline to post-treatment (weeks 0-5)
Blood pressure
Systolic and diastolic blood pressure results will be summarized over the time of the study.
Measured: Baseline to post-treatment (weeks 0-7)
Heart rate
Heart beats per minute will be summarized over the time of the study.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to post-treatment (weeks 0-7)
Alcohol use measures
Drinks per day including days abstained from drinking will be evaluated.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to post-treatment (Weeks 0, 3, 5, 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2017
- Study start1 Mar 2019 (estimated)
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
Why it stopped: Futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmacotherapies for Alcohol and Substance Use Disorders Alliance
- Sponsor type
- University, hospital or other
- Collaborators
- Congressionally Directed Medical Research Programs, Michael E. DeBakey VA Medical Center, Baylor College of Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03376139
- Sponsor's protocol ID
- AS140026-A4
- Other IDs
- W81XWh-15-2-0077
- Status last verified
- Mar 2021
- First submitted
- 13 Nov 2017
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Acheson DT, Geyer MA, Baker DG, Nievergelt CM, Yurgil K, Risbrough VB; MRS-II Team. Conditioned fear and extinction learning performance and its association with psychiatric symptoms in active duty Marines. Psychoneuroendocrinology. 2015 Jan;51:495-505. doi: 10.1016/j.psyneuen.2014.09.030. Epub 2014 Oct 7.
PubMed 25444643Acheson DT, Feifel D, Kamenski M, Mckinney R, Risbrough VB. Intranasal oxytocin administration prior to exposure therapy for arachnophobia impedes treatment response. Depress Anxiety. 2015 Jun;32(6):400-7. doi: 10.1002/da.22362. Epub 2015 Mar 31.
PubMed 25826649Acheson D, Feifel D, de Wilde S, McKinney R, Lohr J, Risbrough V. The effect of intranasal oxytocin treatment on conditioned fear extinction and recall in a healthy human sample. Psychopharmacology (Berl). 2013 Sep;229(1):199-208. doi: 10.1007/s00213-013-3099-4. Epub 2013 May 5.
PubMed 23644911Sullivan JT, Sykora K, Schneiderman J, Naranjo CA, Sellers EM. Assessment of alcohol withdrawal: the revised clinical institute withdrawal assessment for alcohol scale (CIWA-Ar). Br J Addict. 1989 Nov;84(11):1353-7. doi: 10.1111/j.1360-0443.1989.tb00737.x.
PubMed 2597811
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zonisamide as a New Treatment for Post-Traumatic Stress Disorder and Co-Occurring Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT03376139
- Acronym / sponsor ID
- AS140026-A4
- Keywords
- Alcohol, Alcoholic, Alcoholism, Alcohol abuse, Alcohol Use Disorder, Alcohol use, Alcohol dependence, Alcohol dependent
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Futility
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Pharmacotherapies for Alcohol and Substance Use Disorders AllianceUniversity, hospital or other
- Collaborators
- Congressionally Directed Medical Research Programs, Michael E. DeBakey VA Medical Center, Baylor College of Medicine
- Study start
- 1 Mar 2019 (estimated)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 18 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zonisamide (up to 400 mg/day) | Experimental | Drug: ZonisamideZonisamide capsules titrated to a maximum tolerated dose of 400 mg/day for 35 days +/- 4 days, followed by a 14 day down-titration period. |
| Placebo | Placebo comparator | Drug: Placebo ComparatorEncapsulated 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Be willing and able to sign and date an informed consent form
- Be a military service member or Veteran
- Male or female, 18-55 years of age
- Meet Diagnostic and Statistical Manual (DSM)-5 criteria for AUD
- Meet the DSM-5 diagnostic criteria for PTSD; PTSD diagnosis and severity will be determined based on CAPS-5 score greater than or equal to 33
Key exclusion criteria (19 listed)
- DSM-5 criteria for substance use disorders other than alcohol or nicotine or test positive for prescription or illegal drugs. Regarding marijuana/THC, an individual must test negative at the screening. If an individual's test is positive, they will be given a grace period where they will have the opportunity to return and test negative prior to being enrolled.
- Be pregnant or nursing
- Be taking blood pressure medications, psychotropics (with exception of SSRIs/SNRIs), drugs effecting the CNS, medications contraindicated with ethanol, any sulfonamide, or any other medication that could interact with study medications or alter the effects of alcohol.
- Have neurological or psychiatric disorders other than PTSD or AUD (except mild/moderate depression succeeding PTSD). Examples include:
- Have evidence of untreated or unstable medical illness including: cardiovascular, neuroendocrine, autoimmune, renal, hepatic, or active HIV+, AIDS infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZonisamideZonisamide 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 (up to 400 mg/day) |
| Placebo ComparatorEncapsulated 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 |
Primary outcome
Change from baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total symptom severity score
Time frame: Baseline to post-treatment (weeks 0, 3, 5, 7)
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.
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)
Time frame: Baseline to post-treatment (weeks 0-7)
Timeline Follow-Back (TLFB) of self-report assessment of heavy drinking days over the course of the five-week study treatment.
15 secondary outcomes
Severity and numbers of AEs
Time frame: Baseline to post-treatment (weeks 0-7)
Treatment retention
Time frame: Baseline to post-treatment (weeks 0-5)
Medication compliance
Time frame: Baseline to post-treatment (weeks 0-5)
Medication adherence
Time frame: Baseline to post-treatment (weeks 0-5)
Blood pressure
Time frame: Baseline to post-treatment (weeks 0-7)
Heart rate
Time frame: Baseline to post-treatment (weeks 0-7)
ECG abnormalities
Time frame: Baseline to post-treatment (weeks 0-7)
Breath alcohol content (BAC)
Time frame: Baseline to post-treatment (weeks 0-7)
Subjective and psychometric effects of alcohol (e.g. mood, urge/craving)
Time frame: Baseline to post-treatment (weeks 0-7)
Alcohol use measures
Time frame: Baseline to post-treatment (weeks 1, 3, 7)
Presence and symptom assessments for PTSD
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)
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)
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)
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)
Time frame: Baseline to post-treatment (Weeks 0, 3, 5, 7)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- Background: PubMed 25444643Acheson DT, Geyer MA, Baker DG, Nievergelt CM, Yurgil K, Risbrough VB; MRS-II Team. Conditioned fear and extinction learning performance and its association with psychiatric symptoms in active duty Marines. Psychoneuroendocrinology. 2015 Jan;51:495-505. doi: 10.1016/j.psyneuen.2014.09.030. Epub 2014 Oct 7.
- Background: PubMed 25826649Acheson DT, Feifel D, Kamenski M, Mckinney R, Risbrough VB. Intranasal oxytocin administration prior to exposure therapy for arachnophobia impedes treatment response. Depress Anxiety. 2015 Jun;32(6):400-7. doi: 10.1002/da.22362. Epub 2015 Mar 31.
- Background: PubMed 23644911Acheson D, Feifel D, de Wilde S, McKinney R, Lohr J, Risbrough V. The effect of intranasal oxytocin treatment on conditioned fear extinction and recall in a healthy human sample. Psychopharmacology (Berl). 2013 Sep;229(1):199-208. doi: 10.1007/s00213-013-3099-4. Epub 2013 May 5.
- Background: PubMed 2597811Sullivan JT, Sykora K, Schneiderman J, Naranjo CA, Sellers EM. Assessment of alcohol withdrawal: the revised clinical institute withdrawal assessment for alcohol scale (CIWA-Ar). Br J Addict. 1989 Nov;84(11):1353-7. doi: 10.1111/j.1360-0443.1989.tb00737.x.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zonisamide in people with Post Traumatic Stress Disorder and Alcohol Use Disorder, run by Pharmacotherapies for Alcohol and Substance Use Disorders Alliance at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total symptom severity score (time frame: Baseline to post-treatment (weeks 0, 3, 5, 7)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03376139, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2021.