National Adaptive Trial for PTSD Related Insomnia

• Status: Recruiting
• Trial end date: 2024-06-25
• Target enrollment: 0
• Participant gender: All

Summary

Many Veterans with posttraumatic stress disorder (PTSD) have trouble sleeping or have frequent nightmares. So far, no medication has been approved for treatment of insomnia in PTSD. The purpose of this research study is to find out if taking medications called trazodone, eszopiclone, or gabapentin can help decrease symptoms of insomnia in patients with PTSD. PTSD is a form of intense anxiety which sometimes results from severe trauma. Symptoms may include nightmares, flashbacks, troublesome memories, difficulty sleeping, poor concentration, irritability, anger, and emotional withdrawal. Insomnia is a disorder that can make it hard to fall sleep, stay asleep or cause a person to wake up too early and not be able to fall back to sleep.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development
• Treatments: Eszopiclone; Gabapentin; Trazodone

Criteria

Inclusion Criteria:

1. Ability to comprehend and provision of signed and dated informed consent form

2. Stated willingness to comply with all study procedures and availability for the duration of the study (approximately 17 weeks from the date of being randomized)

3. Male or female, between the ages of 18 and 75 years

4. Allow digital recording of phone interviews

5. Military service connected PTSD

6. Primary DSM-5 diagnosis of PTSD, assessed by structured interview using the CAPS-5

7. Total CAPS-5 score 26

8. ISI >15

9. Screening clinical laboratory tests without clinically significant abnormalities as determined by the site investigator with input, if needed, from the study chair

10. Electrocardiogram (ECG) at baseline without clinically significant abnormalities and/or contingent upon approval by consulting medical physician.

11. Females of childbearing potential:

1. Must have a negative pregnancy test during screening

2. Must agree not to become pregnant or breastfeed during the course of the study

3. Must be willing to use a reliable form of contraception for 16 weeks (during study treatment and for 2 weeks after taking the last dose) which includes: barrier contraceptives (male or female condoms with or without a spermicide, diaphragm or cervical cap with spermicide, or intrauterine device) and hormone-based therapy (contraceptive pills, intrauterine devices, or Depo-Provera�)

4. Birth control for female participants is not necessary if surgically sterile or if with a partner with whom they are not capable of conceiving children (defined as a surgically sterile female by hysterectomy, bilateral oophorectomy, or bilateral tubal ligation; surgically sterile male who has undergone a complete orchiectomy or successful vasectomy; or a same sex partner)

11. Agree to secure firearms while receiving study treatment 12. If individuals are undergoing evidence-based psychotherapy which includes: cognitive behavioral therapy (CBT), cognitive processing therapy (CPT), prolonged exposure therapy (PE), and/or stress inoculation therapy (SIT), they must have started these therapies at least 30 days prior to starting screening. (Supportive individual and group therapy is allowed) 13. Agreement to adhere to Lifestyle Considerations throughout study participation

Exclusion Criteria:

1. Currently enrolled in any other interventional study unless prior approval is provided by the study team (It is a CSP policy that exemptions will be assessed for individual patients on a case-by-case basis. Exemptions require the agreement in writing of the following individuals or groups: (1) the SI of both studies; (2) the Study Chairs of the involved studies; (3) the appropriate CSP Center Director(s); and (4) the VA Central IRB.)

2. Allergy and/or history of intolerance to trazodone hydrochloride, gabapentin, and/or eszopiclone

3. A comorbid current or lifetime diagnosis of bipolar I disorder, bipolar II disorder, schizoaffective disorder, schizophrenia or delusional disorder, or current comorbid diagnosis of schizophreniform disorder, brief psychotic disorder, psychotic disorder due to a general medical condition, substance-induced psychotic disorder or psychotic disorder not otherwise specified (NOS) according to Structured Clinical Interview for DSM-5 (SCID)-I-RV/P

4. Clinical evidence of inadequately treated sleep apnea as detected by using ApneaLink to assess the presence of sleep apnea or not

5. History of moderate or severe traumatic brain injury (TBI) or history of gross structural damage as shown on MRI (occurring during period of military service).

6. Positive urine test for an illicit substance, excluding cannabis, within the past 90 days prior to screening

7. Substance use meeting DSM-5 criteria for moderate or severe dependence (excluding nicotine) within the past 12 months prior to screening. (Note: Current mild dependence for alcohol and cannabis use is acceptable, but current mild dependence of any other substances is exclusionary).

8. Inpatient psychiatric hospitalization within 30 days prior to randomization

9. Suicidal or homicidal ideation with intent or plan to harm themselves or others within 90 days prior to randomization

10. Creatinine clearance (CrCl) less than 60 mL/min, or chronic liver disease with two or more of the following occurring within the past six months: international normalized ratio (INR) greater than or equal to 1.7 (not on warfarin therapy), bilirubin greater than or equal to 2 mg/dL, serum albumin less than or equal to 3.5 g/dL, ascites, or encephalopathy (Participants can be reevaluated in 30 days)

11. Clinical and laboratory evidence of untreated hypothyroidism or hyperthyroidism

12. A corrected QT (QTc) interval greater than 470 ms

13. Unstable, serious medical condition or one requiring acute medical treatment, or planned hospitalization for extended care

14. Dementia, epilepsy, stroke, or current treatment with warfarin for anticoagulation

15. Taking any of the exclusionary medications listed in Appendix A. Note- an individual taking one of these medications for the sole purpose of improving sleep that elects to undergo an adequate wash-out period of at least 5 half-lives of the parent compound or active metabolite (e.g., for medications like diazepam), under the care of the individual's clinical provider, wouldn't be excluded by this criterion.

16. Under criminal investigation or pending legal charges with potential incarceration

17. Individuals who lack stable contact information (including lack of a telephone number)

18. Participants who anticipate working during the hours of midnight to 6am during the course of study trial