Zonisamide in Addition to E-CPT-C for Veterans With PTSD and Comorbid Alcohol Dependence
| Status: | Recruiting |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 21 - 65 |
| Updated: | 4/17/2018 |
| Start Date: | June 2013 |
| End Date: | October 2019 |
| Contact: | Elizabeth Ralevski, Ph.D. |
| Email: | elizabeth.ralevski@yale.edu |
| Phone: | (203)932-5711 |
Zonisamide in Addition to Enhanced Cognitive Processing Therapy-C (E-CPT-C) for Veterans With PTSD and Comorbid Alcohol Dependence
This is a randomized, controlled trial with 50 veterans diagnosed with post-traumatic stress
disorder (PTSD) and comorbid alcohol dependence. Veterans will be randomized to receive
either zonisamide (400 mg) or placebo for 12 weeks in a double blind fashion. Randomization
will be done using 3:1 ratio and will be performed by our research pharmacy using a random
assignment in blocks of 4- 3 will be assigned to active medication and 1 to placebo.
Medication will be titrated over a 6 week titration phase followed by a 6 week treatment
phase. All veterans will receive E-CPT-C therapy for the 12 weeks of treatment; E-CPT-C will
be provided by trained and qualified clinicians with extensive experience providing E-CPT-C.
Veterans will be recruited primarily through advertisement, but also through the clinical
facilities at the VA and from other collaborators.
disorder (PTSD) and comorbid alcohol dependence. Veterans will be randomized to receive
either zonisamide (400 mg) or placebo for 12 weeks in a double blind fashion. Randomization
will be done using 3:1 ratio and will be performed by our research pharmacy using a random
assignment in blocks of 4- 3 will be assigned to active medication and 1 to placebo.
Medication will be titrated over a 6 week titration phase followed by a 6 week treatment
phase. All veterans will receive E-CPT-C therapy for the 12 weeks of treatment; E-CPT-C will
be provided by trained and qualified clinicians with extensive experience providing E-CPT-C.
Veterans will be recruited primarily through advertisement, but also through the clinical
facilities at the VA and from other collaborators.
Inclusion Criteria:
- Current alcohol dependence, as determined by a structured clinical interview
(Structured Clinical Interview for DSM-IV Axis I Disorders) (SCID)
- Current PTSD as determined by a structured clinical interview (SCID)
- Veterans with current alcohol dependence, with at least one recent episode of heavy
drinking over the past 14 days.
- Medically and neurologically healthy on the basis of history, physical examination,
EKG, screening laboratories
- For women, negative pregnancy test and use of acceptable method of contraception
Exclusion Criteria:
- Females who are pregnant or lactating.
- Veterans with a current unstable medical condition such as neurological,
cardiovascular, endocrine, renal, liver, or thyroid pathology, which in the opinion of
the physician would preclude the subject from fully cooperating or be of potential
harm during the course of the study
- Veterans who meet current SCID criteria for a major Axis I diagnosis (Bipolar
Disorders, Schizophrenia and Schizophrenia-type Disorders).
- History of substance dependence (other than alcohol, tobacco or cannabis) by DSM-IV
criteria in the last 90 days.
- Veterans taking mood stabilizers and antipsychotic medications for specific
psychiatric disorders.
- Veterans with a history of allergy to zonisamide.
- Veterans already receiving CPT.
We found this trial at
1
site
950 Campbell Ave
West Haven, Connecticut 06516
West Haven, Connecticut 06516
(203) 932-5711
Phone: 203-932-5711
VA Connecticut Healthcare System VA Connecticut encompasses an inpatient facility and Ambulatory Care Center in...
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