The Role of the Opioid System in Placebo Effects on Pain and Social Rejection
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorTrustees of Dartmouth College
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adults aged 18-55 years
No current psychiatric or major neurological diagnosis
No reported substance abuse within the last six months
Are capable of performing experimental tasks (e.g., are able to read, able to cooperate with fMRI examination)
Disqualifiers
Current presence of pain
Current or past history of primary psychiatric disorder
Current or past history of psychoactive substance abuse or dependence
Dementias
Trial design
Design model
Crossover
Treatments tested in this trial
Placebo Cream with Naloxone
DrugParticipants will be informed that the spray is an effective pain and negative emotion reducing agent.
Control Cream with Naloxone
DrugParticipants will be informed that the spray is saline.
Placebo Cream with Saline
DrugParticipants will be informed that the spray is an effective pain and negative emotion reducing agent.
Control Cream with Saline
DrugParticipants will be informed that the spray is saline.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Naloxone GroupExperimental treatment 2 interventions
Group B: Saline GroupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Intervention effects on pain ratings
Pain ratings will be given on a 0-100 scale. 0 being "no pain at all" and 100 being "most pain imaginable in the context of this study."
Time frame
Immediately after pain stimuli2
Intervention effects on negative affect ratings
Rejection ratings will be given on a 0-100 scale. 0 being "not rejected at all" and 100 being "very rejected."
Time frame
Immediately after rejection stimuli3
Brain: Pain signature response
A priori regions of interest response from the brain (fMRI) patterns to the pain.
Time frame
Immediately after pain stimuli4
Brain: Rejection signature response
A priori regions of interest response from the brain (fMRI) patterns to rejection. The investigators will utilize a multivariate brain pattern developed and published in Woo et al., 2014, Nature Communications. This is a rejection-selected pattern of brain activity.
Time frame
Immediately after rejection stimuliSecondary outcomes
1
Whole-brain maps of intervention effects
Standard resting-state images will be acquired for exploratory analyses. Exploratory brain analysis will include univariate voxel-wise maps comparing participant groups with a threshold of q \< 0.05, False Discovery Rate (FDR) corrected.
Time frame
Immediately after pain/rejection stimuli2
Rejection Sensitivity Questionnaire
A measure of sensitivity to actual or perceived rejection with ratings on a 6-point Likert scale ranging from "very unconcerned" - "very concerned." Higher scores indicate more reaction sensitivity.
Time frame
Within 2 weeks before first fMRI scanSponsors and contacts
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Source ClinicalTrials.gov
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