NCT07771530 The Efficacy of a Pharmacological Treatment (Reboxetine Plus Ritalin) Versus Dog-Assisted Therapy in PTSD
| NCT ID | NCT07771530 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Haifa |
| Condition | PTSD |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2026-08-01 |
| Primary Completion | 2028-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 160 participants in total. It began in 2026-08-01 with a primary completion date of 2028-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Posttraumatic stress disorder (PTSD) is a chronic and often treatment-resistant psychiatric condition that emerges following exposure to trauma and is characterized by intrusive thoughts, emotional dysregulation, and cognitive impairments. In Israel, the prevalence of PTSD has increased significantly in the aftermath of the October 7, 2023 terror attacks, emphasizing the urgent need for more effective, accessible, and personalized interventions. Existing treatments, such as trauma-focused CBT and SSRIs, remain only partially effective, with side effects that reduce adherence and limit long-term recovery. The proposed randomized controlled trial will assess and compare two promising treatment modalities: (i) a new pharmacological combination of reboxetine and methylphenidate, designed to enhance noradrenergic and dopaminergic pathways involved in attention and emotional regulation, and (ii) dog-assisted therapy (DAT), a non-pharmacological, group-based intervention shown to reduce PTSD symptoms and improve functioning. One hundred sixty adults with PTSD will be randomized into four groups: pharmacological treatment, placebo, DAT, or occupational therapy. The study will use validated clinical scales (CAPS-5, GAD-7, CAARS, DLQ, WHOQOLBREF) alongside neurophysiological tools (EEG, EDA, ASAT-based EMG). Data will feed into a machine-learning model to identify predictors of treatment response and support the development of personalized, neurobiologically informed approaches.
Eligibility Criteria
Inclusion Criteria: * age between 18 and 70 years, * diagnosed with PTSD according to DSM-IV or DSM-5 criteria, * any psychotropic drug therapy that is being administered must be at a fixed dose for at least one month prior to the study initiation. Exclusion Criteria: * any health condition for which the use of reboxetine or methylphenidate is contraindicated, * comorbidity with major psychiatric disorder, * significant/active cardiovascular disease, * previous or current severe traumatic brain injury, * active substance dependency, * participating in another treatment program for PTSD of any kind.
Contact & Investigator
Avi Avital, PhD
PRINCIPAL INVESTIGATOR
University of Haifa
Frequently Asked Questions
Who can join the NCT07771530 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying PTSD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07771530 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07771530 currently recruiting?
Yes, NCT07771530 is actively recruiting participants. Contact the research team at avitalavi@hotmail.com for enrollment information.
Where is the NCT07771530 trial being conducted?
This trial is being conducted at Haifa, Israel.
Who is sponsoring the NCT07771530 clinical trial?
NCT07771530 is sponsored by University of Haifa. The principal investigator is Avi Avital, PhD at University of Haifa. The trial plans to enroll 160 participants.
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