PainPhase 1NCT03060031
Effects of Intranasal Oxytocin Administration on Social Influence Effects on Pain
A Phase 1 study testing Oxytocin in people with Pain, run by University of Colorado, Boulder at 1 site in United States.
Trial summary
This experiment will explore the joint effects of social information, social support, associative learning, and oxytocin on the development of placebo analgesia. The investigators predict that socially transmitted placebo effects will be enhanced by nasal administration of oxytocin, whereas associative learning… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Oxytocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2017to 1 Apr 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is a volunteer between 18 and 40 years of age.
- If female, subject is non-lactating, not pregnant, and using a reliable contraception method
- Subject is able to read and speak English.
- Subject is able and willing to provide written informed consent.
- Subject is able to understand and follow the instructions of the investigator and understand all screening questionnaires.
- Subject is in good health.
- For participants to be eligible for all tasks of the study, the participant must have a romantic partner and be willing to bring the partner to the study session.
Who cannot join
- Tests positive on the 14 panel poly-substance urine drug screen for illicit substances (e.g., marijuana (THC), cocaine (COC), phencyclidine (PCP), amphetamine (AMP), ecstasy (MDMA), methamphetamine (Mamp), opiates (OPI), oxycodone (OXY), methadone (MTD), barbiturates (BAR), benzodiazepines (BZO), buprenorphine (BUP), tricyclic antidepressants (TCA), propoxyphene (PPX))
- Chronic Pain
- Do not have the ability to tolerate heat pain applied to the forearm
- Have temporary abnormal levels of pain
- Have score of > 19 using the Center for Disease and Epidemiology Depression Scale
- Current treatment (e.g., medications or therapy) for psychiatric disorders, including mood, anxiety, substance abuse, Attention-deficit/hyperactivity disorder (ADHD), psychosis; Neurological disorders (e.g., taking dopamine agonists for Parkinson's); Cardiovascular disease or medication (e.g., taking ACE (angiotensin-converting-enzyme) inhibitors for cardiac remodeling)
- Frequent smoking (> 5 cigarettes / day); frequent alcohol use (>14 drinks / week); frequent migraines (> 5 / month on average) or a history of neurologic disease or neuropathic pain.
- Any allergy to Oxytocin
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Translational Research Center
Boulder, Colorado, 80309
About this study
Official title: Effects of Oxytocin Administration on Social Influence Effects on Pain
This experiment will explore the joint effects of social information, social support, associative learning, and oxytocin on the development of placebo analgesia. The investigators predict that socially transmitted placebo effects will be enhanced by nasal administration of oxytocin, whereas associative learning effects on pain will not be altered by this pharmacological manipulation
Read the detailed description
Background:
The placebo literature suggests that both conceptual (i.e. socially instructed beliefs) and associative learning processes are critical for the genesis of placebo effects. Several studies have performed placebo 'conditioning' (associating a sham treatment with reduced pain through repeated experience) but interfered with conceptual processing by informing subjects that the intensity of the stimulus was being lowered. This manipulation prevented the attribution of pain reductions to the placebo treatment during the learning process. These studies showed no conditioned analgesia. However, when the same 'conditioning' was performed without the verbal explanation for why the treatment seemed to work, robust placebo effects were created. Conceptual processes appear to be critical. Conversely, several studies have manipulated conceptual expectations alone, by manipulating verbal instructions, and have found markedly reduced or absent placebo analgesia on both pain report and brain event-related potentials. Learning by experience also seems to be critical.
These studies separately have led to the conclusions that 'expectancy' and 'conditioning' are each critical processes, and debates have focused on which one is the driver of placebo effects. The investigators propose another view: Both processes are critical, and they interact. Experience drives changes in value learning systems, but in any type of value learning, there is a 'credit assignment' problem, and the brain must decide which cue-outcome associations to update as a result of experience: Is the pain reduced because the treatment was effective or because the cause of pain changed? Conceptual processes fill the gap, drawing on explicit memory and generalization from similar past experiences to solve the credit assignment problem, creating analgesia if experienced relief is attributed to the treatment. This view is compatible with older information based theories of conditioning and new evidence that rats and humans alike maintain expectancies about specific outcomes and mental models of contingencies that are distinct from associative learning. In spite of dozens of published studies demonstrating effective placebo analgesia with the established paradigm the investigators use, the precise nature of the learning that occurs is unknown, because placebo analgesia has not typically been studied from a learning-systems perspective. The aim of the present study is to assess the influence of social information and associative learning on placebo analgesia.
In addition, interactions between neurochemical systems and placebo analgesia have hardly been explored, and this proposal represents a significant effort in that regard. For example, oxytocin interacts synergistically with opioids in the PAG (periaqueductal gray) (and CCK (Cholecystokinin)) to relieve pain, and in a separate literature reliably increases trust and reduces anxiety in interpersonal situations. In spite of the fact that oxytocin has been proposed as central to the placebo effect and can be administered to humans with no known subjective effects or side effects, its role in placebo analgesia has not been explored extensively. The experiment proposed here will clarify the roles of the oxytocin system and its contributions to social facilitation of analgesia, and will be instrumental in developing a systems-based model of placebo effects.
Experimental Design:
Participants will perform two tasks in each experimental session. First, they will perform a social-influence and learning task to investigate the effects of oxytocin on social instruction effects and learning on pain. Second, they will perform a social-support during pain, to test the effects of oxytocin on the pain-alleviating effects of social support during pain.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called Syntocinon
Oxytocin intranasal administration, 40 IU, 5 puffs per nostril at 4 IU per puff delivered approximately 45 minutes prior to pain tasks.
PlaceboDrug
Placebo intranasal administration, 5 puffs per nostril delivered approximately 45 minutes prior to pain tasks
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin | Experimental | Each participant will undergo pain tasks after self-administration of oxytocin Receives: Drug: Oxytocin |
| Placebo | Placebo comparator | Each participant will undergo pain tasks after self-administration of placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain expectation rating score made on a Visual Analog Scale (VAS) after administration of Oxytocin vs. Placebo
Self reported expectation of pain intensity using the VAS ranging from 0-100 (with 0 representing "no pain at all" and 100 representing "most intense pain imaginable (in the context of the experiment)).
Measured: Measured during pain tasks at session 1 (within one month of screening survey completion) and 2 which will be within one week of each other.
Change in pain rating score made on a Visual Analog Scale (VAS) after administration of Oxytocin vs. Placebo
Self reported pain intensity using the VAS ranging from 0-100 (with 0 representing "no pain at all" and 100 representing "most intense pain imaginable (in the context of the experiment)).
Measured: Measured during pain tasks at session 1(within one month of screening survey completion) and 2 which will be within one week of each other.
Change in pain unpleasantness rating score during hand holding and control conditions made on a Visual Analog Scale (VAS) after administration of Oxytocin vs. Placebo
Self reported pain unpleasantness using the VAS ranging from 0-100 (with 0 representing "no pain at all" and 100 representing "most intense pain imaginable (in the context of the experiment)).
Measured: Measured during pain tasks at session 1 (within one month of screening survey completion)and 2 which will be within one week of each other.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start21 Jun 2017
- Primary completion5 Mar 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- 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
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Boulder
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tor Wager, University of Colorado, Boulder
- Investigators
- Tor D Wager, Ph. D., Principal investigator, University of Colorado, Boulder
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03060031
- Sponsor's protocol ID
- GRANT11076934
- Status last verified
- Jun 2019
- First submitted
- 8 Feb 2017
- Last updated
- 25 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Montgomery GH, Kirsch I. Classical conditioning and the placebo effect. Pain. 1997 Aug;72(1-2):107-13. doi: 10.1016/s0304-3959(97)00016-x.
PubMed 9272794Morton DL, Watson A, El-Deredy W, Jones AK. Reproducibility of placebo analgesia: Effect of dispositional optimism. Pain. 2009 Nov;146(1-2):194-8. doi: 10.1016/j.pain.2009.07.026. Epub 2009 Aug 18.
PubMed 19692178Watson A, El-Deredy W, Iannetti GD, Lloyd D, Tracey I, Vogt BA, Nadeau V, Jones AK. Placebo conditioning and placebo analgesia modulate a common brain network during pain anticipation and perception. Pain. 2009 Sep;145(1-2):24-30. doi: 10.1016/j.pain.2009.04.003. Epub 2009 Jun 11.
PubMed 19523766Watson A, El-Deredy W, Vogt BA, Jones AK. Placebo analgesia is not due to compliance or habituation: EEG and behavioural evidence. Neuroreport. 2007 May 28;18(8):771-5. doi: 10.1097/WNR.0b013e3280c1e2a8.
PubMed 17471064Petrovic P, Kalso E, Petersson KM, Ingvar M. Placebo and opioid analgesia-- imaging a shared neuronal network. Science. 2002 Mar 1;295(5560):1737-40. doi: 10.1126/science.1067176. Epub 2002 Feb 7.
PubMed 11834781Wager TD, Rilling JK, Smith EE, Sokolik A, Casey KL, Davidson RJ, Kosslyn SM, Rose RM, Cohen JD. Placebo-induced changes in FMRI in the anticipation and experience of pain. Science. 2004 Feb 20;303(5661):1162-7. doi: 10.1126/science.1093065.
PubMed 14976306Zubieta JK, Bueller JA, Jackson LR, Scott DJ, Xu Y, Koeppe RA, Nichols TE, Stohler CS. Placebo effects mediated by endogenous opioid activity on mu-opioid receptors. J Neurosci. 2005 Aug 24;25(34):7754-62. doi: 10.1523/JNEUROSCI.0439-05.2005.
PubMed 16120776Colloca L, Tinazzi M, Recchia S, Le Pera D, Fiaschi A, Benedetti F, Valeriani M. Learning potentiates neurophysiological and behavioral placebo analgesic responses. Pain. 2008 Oct 15;139(2):306-314. doi: 10.1016/j.pain.2008.04.021. Epub 2008 Jun 6.
PubMed 18538928Kirsch I. Conditioning, expectancy, and the placebo effect: comment on Stewart-Williams and Podd (2004). Psychol Bull. 2004 Mar;130(2):341-3; discussion 344-5. doi: 10.1037/0033-2909.130.2.341.
PubMed 14979776Stewart-Williams S, Podd J. The placebo effect: dissolving the expectancy versus conditioning debate. Psychol Bull. 2004 Mar;130(2):324-40. doi: 10.1037/0033-2909.130.2.324.
PubMed 14979775Voudouris NJ, Peck CL, Coleman G. The role of conditioning and verbal expectancy in the placebo response. Pain. 1990 Oct;43(1):121-128. doi: 10.1016/0304-3959(90)90057-K.
PubMed 2277714Rescorla RA. Pavlovian conditioning. It's not what you think it is. Am Psychol. 1988 Mar;43(3):151-60. doi: 10.1037//0003-066x.43.3.151. No abstract available.
PubMed 3364852Schoenbaum G, Roesch M. Orbitofrontal cortex, associative learning, and expectancies. Neuron. 2005 Sep 1;47(5):633-6. doi: 10.1016/j.neuron.2005.07.018.
PubMed 16129393Balleine BW, O'Doherty JP. Human and rodent homologies in action control: corticostriatal determinants of goal-directed and habitual action. Neuropsychopharmacology. 2010 Jan;35(1):48-69. doi: 10.1038/npp.2009.131.
PubMed 19776734Ostlund SB, Balleine BW. Lesions of medial prefrontal cortex disrupt the acquisition but not the expression of goal-directed learning. J Neurosci. 2005 Aug 24;25(34):7763-70. doi: 10.1523/JNEUROSCI.1921-05.2005.
PubMed 16120777
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oxytocin Administration on Social Influence Effects on Pain
- ClinicalTrials.gov ID
- NCT03060031
- Acronym / sponsor ID
- GRANT11076934
- Conditions
- Pain
- Keywords
- Oxytocin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of Colorado, BoulderUniversity, hospital or other
- Study start
- 21 Jun 2017 (actual)
- Primary completion
- 5 Mar 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 23 Feb 2017 (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.
This experiment will explore the joint effects of social information, social support, associative learning, and oxytocin on the development of placebo analgesia. The investigators predict that socially transmitted placebo effects will be enhanced by nasal administration of oxytocin, whereas associative learning effects on pain will not be altered by this pharmacological manipulation
Detailed description
Background:
The placebo literature suggests that both conceptual (i.e. socially instructed beliefs) and associative learning processes are critical for the genesis of placebo effects. Several studies have performed placebo 'conditioning' (associating a sham treatment with reduced pain through repeated experience) but interfered with conceptual processing by informing subjects that the intensity of the stimulus was being lowered. This manipulation prevented the attribution of pain reductions to the placebo treatment during the learning process. These studies showed no conditioned analgesia. However, when the same 'conditioning' was performed without the verbal explanation for why the treatment seemed to work, robust placebo effects were created. Conceptual processes appear to be critical. Conversely, several studies have manipulated conceptual expectations alone, by manipulating verbal instructions, and have found markedly reduced or absent placebo analgesia on both pain report and brain event-related potentials. Learning by experience also seems to be critical.
These studies separately have led to the conclusions that 'expectancy' and 'conditioning' are each critical processes, and debates have focused on which one is the driver of placebo effects. The investigators propose another view: Both processes are critical, and they interact. Experience drives changes in value learning systems, but in any type of value learning, there is a 'credit assignment' problem, and the brain must decide which cue-outcome associations to update as a result of experience: Is the pain reduced because the treatment was effective or because the cause of pain changed? Conceptual processes fill the gap, drawing on explicit memory and generalization from similar past experiences to solve the credit assignment problem, creating analgesia if experienced relief is attributed to the treatment. This view is compatible with older information based theories of conditioning and new evidence that rats and humans alike maintain expectancies about specific outcomes and mental models of contingencies that are distinct from associative learning. In spite of dozens of published studies demonstrating effective placebo analgesia with the established paradigm the investigators use, the precise nature of the learning that occurs is unknown, because placebo analgesia has not typically been studied from a learning-systems perspective. The aim of the present study is to assess the influence of social information and associative learning on placebo analgesia.
In addition, interactions between neurochemical systems and placebo analgesia have hardly been explored, and this proposal represents a significant effort in that regard. For example, oxytocin interacts synergistically with opioids in the PAG (periaqueductal gray) (and CCK (Cholecystokinin)) to relieve pain, and in a separate literature reliably increases trust and reduces anxiety in interpersonal situations. In spite of the fact that oxytocin has been proposed as central to the placebo effect and can be administered to humans with no known subjective effects or side effects, its role in placebo analgesia has not been explored extensively. The experiment proposed here will clarify the roles of the oxytocin system and its contributions to social facilitation of analgesia, and will be instrumental in developing a systems-based model of placebo effects.
Experimental Design:
Participants will perform two tasks in each experimental session. First, they will perform a social-influence and learning task to investigate the effects of oxytocin on social instruction effects and learning on pain. Second, they will perform a social-support during pain, to test the effects of oxytocin on the pain-alleviating effects of social support during pain.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxytocin | Experimental | Drug: OxytocinEach participant will undergo pain tasks after self-administration of oxytocin |
| Placebo | Placebo comparator | Drug: PlaceboEach participant will undergo pain tasks after self-administration of placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subject is a volunteer between 18 and 40 years of age.
- If female, subject is non-lactating, not pregnant, and using a reliable contraception method
- Subject is able to read and speak English.
- Subject is able and willing to provide written informed consent.
- Subject is able to understand and follow the instructions of the investigator and understand all screening questionnaires.
Key exclusion criteria (8 listed)
- Tests positive on the 14 panel poly-substance urine drug screen for illicit substances (e.g., marijuana (THC), cocaine (COC), phencyclidine (PCP), amphetamine (AMP), ecstasy (MDMA), methamphetamine (Mamp), opiates (OPI), oxycodone (OXY), methadone (MTD), barbiturates (BAR), benzodiazepines (BZO), buprenorphine (BUP), tricyclic antidepressants (TCA), propoxyphene (PPX))
- Chronic Pain
- Do not have the ability to tolerate heat pain applied to the forearm
- Have temporary abnormal levels of pain
- Have score of > 19 using the Center for Disease and Epidemiology Depression Scale
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 |
|---|---|---|
| OxytocinAlso: SyntocinonOxytocin intranasal administration, 40 IU, 5 puffs per nostril at 4 IU per puff delivered approximately 45 minutes prior to pain tasks. | Drug | Oxytocin |
| PlaceboPlacebo intranasal administration, 5 puffs per nostril delivered approximately 45 minutes prior to pain tasks | Drug | Placebo |
Primary outcome
Change in pain expectation rating score made on a Visual Analog Scale (VAS) after administration of Oxytocin vs. Placebo
Time frame: Measured during pain tasks at session 1 (within one month of screening survey completion) and 2 which will be within one week of each other.
Self reported expectation of pain intensity using the VAS ranging from 0-100 (with 0 representing "no pain at all" and 100 representing "most intense pain imaginable (in the context of the experiment)).
Change in pain rating score made on a Visual Analog Scale (VAS) after administration of Oxytocin vs. Placebo
Time frame: Measured during pain tasks at session 1(within one month of screening survey completion) and 2 which will be within one week of each other.
Self reported pain intensity using the VAS ranging from 0-100 (with 0 representing "no pain at all" and 100 representing "most intense pain imaginable (in the context of the experiment)).
Change in pain unpleasantness rating score during hand holding and control conditions made on a Visual Analog Scale (VAS) after administration of Oxytocin vs. Placebo
Time frame: Measured during pain tasks at session 1 (within one month of screening survey completion)and 2 which will be within one week of each other.
Self reported pain unpleasantness using the VAS ranging from 0-100 (with 0 representing "no pain at all" and 100 representing "most intense pain imaginable (in the context of the experiment)).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2019.
- Background: PubMed 9272794Montgomery GH, Kirsch I. Classical conditioning and the placebo effect. Pain. 1997 Aug;72(1-2):107-13. doi: 10.1016/s0304-3959(97)00016-x.
- Background: PubMed 19692178Morton DL, Watson A, El-Deredy W, Jones AK. Reproducibility of placebo analgesia: Effect of dispositional optimism. Pain. 2009 Nov;146(1-2):194-8. doi: 10.1016/j.pain.2009.07.026. Epub 2009 Aug 18.
- Background: PubMed 19523766Watson A, El-Deredy W, Iannetti GD, Lloyd D, Tracey I, Vogt BA, Nadeau V, Jones AK. Placebo conditioning and placebo analgesia modulate a common brain network during pain anticipation and perception. Pain. 2009 Sep;145(1-2):24-30. doi: 10.1016/j.pain.2009.04.003. Epub 2009 Jun 11.
- Background: PubMed 17471064Watson A, El-Deredy W, Vogt BA, Jones AK. Placebo analgesia is not due to compliance or habituation: EEG and behavioural evidence. Neuroreport. 2007 May 28;18(8):771-5. doi: 10.1097/WNR.0b013e3280c1e2a8.
- Background: PubMed 11834781Petrovic P, Kalso E, Petersson KM, Ingvar M. Placebo and opioid analgesia-- imaging a shared neuronal network. Science. 2002 Mar 1;295(5560):1737-40. doi: 10.1126/science.1067176. Epub 2002 Feb 7.
- Background: PubMed 14976306Wager TD, Rilling JK, Smith EE, Sokolik A, Casey KL, Davidson RJ, Kosslyn SM, Rose RM, Cohen JD. Placebo-induced changes in FMRI in the anticipation and experience of pain. Science. 2004 Feb 20;303(5661):1162-7. doi: 10.1126/science.1093065.
- Background: PubMed 16120776Zubieta JK, Bueller JA, Jackson LR, Scott DJ, Xu Y, Koeppe RA, Nichols TE, Stohler CS. Placebo effects mediated by endogenous opioid activity on mu-opioid receptors. J Neurosci. 2005 Aug 24;25(34):7754-62. doi: 10.1523/JNEUROSCI.0439-05.2005.
- Background: PubMed 18538928Colloca L, Tinazzi M, Recchia S, Le Pera D, Fiaschi A, Benedetti F, Valeriani M. Learning potentiates neurophysiological and behavioral placebo analgesic responses. Pain. 2008 Oct 15;139(2):306-314. doi: 10.1016/j.pain.2008.04.021. Epub 2008 Jun 6.
- Background: PubMed 14979776Kirsch I. Conditioning, expectancy, and the placebo effect: comment on Stewart-Williams and Podd (2004). Psychol Bull. 2004 Mar;130(2):341-3; discussion 344-5. doi: 10.1037/0033-2909.130.2.341.
- Background: PubMed 14979775Stewart-Williams S, Podd J. The placebo effect: dissolving the expectancy versus conditioning debate. Psychol Bull. 2004 Mar;130(2):324-40. doi: 10.1037/0033-2909.130.2.324.
- Background: PubMed 2277714Voudouris NJ, Peck CL, Coleman G. The role of conditioning and verbal expectancy in the placebo response. Pain. 1990 Oct;43(1):121-128. doi: 10.1016/0304-3959(90)90057-K.
- Background: PubMed 3364852Rescorla RA. Pavlovian conditioning. It's not what you think it is. Am Psychol. 1988 Mar;43(3):151-60. doi: 10.1037//0003-066x.43.3.151. No abstract available.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Tor D Wager, Ph. D. principal investigator
University of Colorado, Boulder
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oxytocin in people with Pain, run by University of Colorado, Boulder 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 7 inclusion and 8 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: finished, as of the sponsor's last update on 25 Jun 2019. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain expectation rating score made on a Visual Analog Scale (VAS) after administration of Oxytocin vs. Placebo (time frame: Measured during pain tasks at session 1 (within one month of screening survey completion) and 2 which will be within one week of each other.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03060031, which also lists 35 linked publications.
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 25 Jun 2019.