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Opioid System's Role in Placebo Effects for Pain

Phase < 1
Waitlist Available
Led By Tor D Wager, PhD
Research Sponsored by Trustees of Dartmouth College
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No current or recent history of pathological pain or reported neurological disorders
No current psychiatric or major neurological diagnosis
Must not have
Current presence of pain
Uncontrolled hypertension or hypotension
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately after pain/rejection stimuli
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions

Summary

This trial is investigating whether the opioid system is involved in the placebo effect of social pain relief. 60 participants who have recently experienced an unwanted breakup will be exposed to rejection-related stimuli and given painful heat and pressure stimuli during fMRI scanning. They will be randomized to receive either a naloxone or saline nasal spray, and be told that the spray is either saline or an effective pain and negative emotion reducing agent.

Who is the study for?
This trial is for adults aged 18-55 who speak English and have recently gone through an unwanted breakup. They must not have psychiatric/neurological disorders, substance abuse history in the last six months, or any conditions that would interfere with MRI scanning. Participants should not be on certain medications or have metal implants due to MRI requirements.
What is being tested?
The study tests how a placebo cream combined with either naloxone (blocks opioid effects) or saline affects pain and feelings of social rejection after a breakup. During fMRI scans, participants will face rejection stimuli and painful sensations while being told they're receiving a treatment that could reduce pain and negative emotions.
What are the potential side effects?
Since this trial involves placebos and naloxone which may temporarily block natural pain-relief mechanisms, possible side effects include increased sensitivity to pain or discomfort during the testing period.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I do not have ongoing or recent severe pain or neurological disorders.
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I do not have a psychiatric or major neurological condition.
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I am between 18 and 55 years old.
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I am fluent in English.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently experiencing pain.
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My blood pressure is not stable.
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I suffer from long-term pain.
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I have had a stroke or mini-strokes before.
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I have a neuroendocrine disorder like Cushing's disease.
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I have a condition like multiple sclerosis affecting my brain or spinal cord.
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I have a condition related to inflammation of the blood vessels in my brain, or an autoimmune disease.
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I have had a head injury that made me lose consciousness.
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I have a tumor or mass in my body.
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I have not had a heart attack or severe heart disease in the last two years.
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I have or had cancer.
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My thyroid condition is not being treated.
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I do not have a brain infection.
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I have a seizure disorder.
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I have metal in my body or have worked with metal fragments.
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I am not pregnant.
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I have a movement disorder that is not familial tremor.
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I have been diagnosed with chronic fatigue syndrome.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately after rejection stimuli
This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately after rejection stimuli for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Brain: Pain signature response
Brain: Rejection signature response
Heart rate
+3 more
Secondary study objectives
Rejection Sensitivity Questionnaire
Whole-brain maps of intervention effects

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Saline GroupExperimental Treatment2 Interventions
Participants will receive saline in the nasal spray.
Group II: Naloxone GroupExperimental Treatment2 Interventions
Participants will receive 4mg naloxone nasal spray.

Find a Location

Who is running the clinical trial?

Trustees of Dartmouth CollegeLead Sponsor
29 Previous Clinical Trials
11,430 Total Patients Enrolled
1 Trials studying Placebo Effect
120 Patients Enrolled for Placebo Effect
Tor D Wager, PhDPrincipal InvestigatorDartmouth College
5 Previous Clinical Trials
473 Total Patients Enrolled
1 Trials studying Placebo Effect
120 Patients Enrolled for Placebo Effect

Media Library

Control Cream with Naloxone Clinical Trial Eligibility Overview. Trial Name: NCT04650841 — Phase < 1
Placebo Effect Research Study Groups: Saline Group, Naloxone Group
Placebo Effect Clinical Trial 2023: Control Cream with Naloxone Highlights & Side Effects. Trial Name: NCT04650841 — Phase < 1
Control Cream with Naloxone 2023 Treatment Timeline for Medical Study. Trial Name: NCT04650841 — Phase < 1
~40 spots leftby Mar 2026
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