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The Role of the Opioid System in Placebo Effects on Pain and Social Rejection

StatusNot Yet Recruiting
PhaseEarly Phase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary and study completion dates: Mar 1, 2026 to Mar 1, 2027 Start date: Sep 1, 2025 to Sep 1, 2026v7 Show 1 more changeShow less
    • Start date: Sep 1, 2025 to Sep 1, 2026
  2. Primary and study completion dates: Mar 1, 2025 to Mar 1, 2026 Start date: Sep 1, 2024 to Sep 1, 2025v6 Show 1 more changeShow less
    • Start date: Sep 1, 2024 to Sep 1, 2025
  3. Primary and study completion dates: Mar 1, 2024 to Mar 1, 2025 Start date: Sep 1, 2023 to Sep 1, 2024v5 Show 1 more changeShow less
    • Start date: Sep 1, 2023 to Sep 1, 2024
  4. Start date: Sep 1, 2022 to Sep 1, 2023v4
  5. Primary and study completion dates: Mar 1, 2023 to Mar 1, 2024 Start date: Sep 1, 2021 to Sep 1, 2022v3 Show 1 more changeShow less
    • Start date: Sep 1, 2021 to Sep 1, 2022
  6. Interventions: Control Cream (Behavioral), Placebo Cream (Drug) to Control Cream with Naloxone (Drug), Control Cream with Saline (Drug), Placebo Cream with Naloxone (Drug), Placebo Cream with Saline (Drug) Secondary endpoints: details revised at 1 of 2 entriesv2 Show 1 more changeShow less
    • Secondary endpoints: details revised at 1 of 2 entries
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The current study probes the involvement of the opioid system in placebo effects on social pain, using the opioid antagonist naloxone. 60 participants who recently experienced an unwanted breakup will experience rejection-related stimuli and receive painful heat and pressure stimuli during fMRI scanning. Participants will be randomized to receive either a naloxone or saline nasal spray, and be informed that the spray is either saline, or an effective pain and negative emotion reducing agent.
Trial Details
NCT Number NCT04650841
Lead Sponsor Trustees of Dartmouth College
Conditions Pain, Rejection, Placebo Effect
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov