Drug LikingEarly Phase 1NCT07348172
Characterizing Drug Liking During Drug Administration in Peri-procedural Clinical Settings
A Early Phase 1 study testing Amisulpride in people with Drug Liking, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate whether medications used in peri-procedural clinical settings can modulate drug liking. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Liking
- What is being tested?
- Amisulpride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2026to 31 Mar 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status classification of I, II or III
- Candidates who are expected to receive fentanyl up to 3 mcg/kg IBW for their scheduled for surgery or procedure
Who cannot join
- Craniofacial abnormalities
- Known or suspected difficult intubation or mask ventilation
- Known or suspected need for rapid sequence induction and intubation
- Allergies or hypersensitivities to amisulpride or fentanyl
- Clinically significant pulmonary disease, such as chronic obstructive lung disease requiring long-term oxygen therapy, or other conditions that, in the study team's judgment, may increase the risk of severe respiratory depression with opioid administration
- History of long QT syndrome
Show all 19Show fewer
- Any heart rhythm other than normal sinus rhythm (including but not limited to atrial fibrillation, atrial flutter, paced rhythms, ventricular tachycardia, or any supraventricular tachycardia)
- History of Torsades de Pointes
- History of psychosis
- History of movement disorders e.g. Parkinson's Disease
- Past chronic use of anti-psychotics
- Current use of amisulpride, droperidol, levodopa, lithium, clozapine, metoclopramide, benzodiazepines
- Current use of opioids
- History of opiate abuse within the last 3 years
- Known or suspected severe chronic pain condition that require use of opiates or limit daily activities
- History of pheochromocytoma
- History of concomitant prolactin-dependent tumors e.g. prolactinoma, breast cancer
- Pregnancy or nursing
- Failure to satisfy the investigator of fitness to participate for any other reason
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Stanford Hospital
Palo Alto, California, 94304
Patrick Principal Investigator, 6179706739, ppurdon@stanford.edu
About this study
The purpose of this study is to evaluate whether medications used in peri-procedural clinical settings can modulate drug liking.
Read the detailed description
Specifically, we aim to measure differences in drug liking with a VAS (0 - 100) questionnaire. Additionally, we will monitor neural activity recording a frontal electroencephalogram (EEG) to detect changes in brain signals associated with opioid drug effects. By comparing behavioral and neurophysiological data across treatment and control groups, this study seeks to explore the therapeutic potential of this medication.
- Conditions
- Drug Liking
- Being tested
- Amisulpride, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmisulprideDrug
Medication administered as a single intravenous dose.
PlaceboDrug
Matching Placebo given by single intravenous (IV) administration.
| Study group | Role | What they receive |
|---|---|---|
| Drug | Experimental | Participants receive study drug prior to fentanyl administration before their procedure. Receives: Drug: Amisulpride |
| Placebo | Placebo comparator | Participants receive placebo prior to fentanyl administration before their procedure. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Drug Liking Rating
Change in drug liking rating (0-100), anchored by divert "not at all=0" and "as much as possible=100".
Measured: One minute before and 1, 3, and 5 minutes after fentanyl administration
Secondary outcomes (2)
EEG band power
Assessment of the change in power of the frontal EEG canonical frequency bands measured in decibles (dB).
Measured: From administration of the study drug to about 1 hour after.
Change in Sedation Rating
Change in self-reported sedation rating (0-100), anchored by divert "not at all=0" and "as much as possible=100".
Measured: One minute before and 1, 3, and 5 minutes after fentanyl administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start1 Mar 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug LikingStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Purdon, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07348172
- Sponsor's protocol ID
- IRB-80824
- Status last verified
- Jan 2026
- First submitted
- 8 Jan 2026
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing Drug Liking During Drug Administration in Peri-procedural Clinical Settings
- ClinicalTrials.gov ID
- NCT07348172
- Acronym / sponsor ID
- IRB-80824
- Conditions
- Drug Liking
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate whether medications used in peri-procedural clinical settings can modulate drug liking.
Detailed description
Specifically, we aim to measure differences in drug liking with a VAS (0 - 100) questionnaire. Additionally, we will monitor neural activity recording a frontal electroencephalogram (EEG) to detect changes in brain signals associated with opioid drug effects. By comparing behavioral and neurophysiological data across treatment and control groups, this study seeks to explore the therapeutic potential of this medication.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug | Experimental | Drug: AmisulprideParticipants receive study drug prior to fentanyl administration before their procedure. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants receive placebo prior to fentanyl administration before their procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) physical status classification of I, II or III
- Candidates who are expected to receive fentanyl up to 3 mcg/kg IBW for their scheduled for surgery or procedure
Key exclusion criteria (19 listed)
- Craniofacial abnormalities
- Known or suspected difficult intubation or mask ventilation
- Known or suspected need for rapid sequence induction and intubation
- Allergies or hypersensitivities to amisulpride or fentanyl
- Clinically significant pulmonary disease, such as chronic obstructive lung disease requiring long-term oxygen therapy, or other conditions that, in the study team's judgment, may increase the risk of severe respiratory depression with opioid administration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmisulprideMedication administered as a single intravenous dose. | Drug | Drug |
| PlaceboMatching Placebo given by single intravenous (IV) administration. | Drug | Placebo |
Primary outcome
Change in Drug Liking Rating
Time frame: One minute before and 1, 3, and 5 minutes after fentanyl administration
Change in drug liking rating (0-100), anchored by divert "not at all=0" and "as much as possible=100".
2 secondary outcomes
EEG band power
Time frame: From administration of the study drug to about 1 hour after.
Change in Sedation Rating
Time frame: One minute before and 1, 3, and 5 minutes after fentanyl administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Drug Liking
RecruitingPhase 2
Study of Olatorepatide in Adult Participants Living With Overweight or Obesity Without Diabetes
Overweight or Obesity
RecruitingPhase 2
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
Bladder Adenocarcinoma, Bladder Clear Cell Adenocarcinoma
Not yet recruitingPhase 2
Semaglutide for Weight Management During Hormone Therapy for Early Breast Cancer
Breast Cancer (Early Breast Cancer), Obesity
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruiting
Exploring the Influence of Glucagon-like Peptide -1 (GLP-1) Medications on Food Cravings, Food Selection, and Food Intake Following Exposure to Food Advertisements
GLP - 1
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Amisulpride in people with Drug Liking, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrick L Purdon, PhD (6507367331, ppurdon@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Drug Liking Rating (time frame: One minute before and 1, 3, and 5 minutes after fentanyl administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.