Phase 2
N=20
Deciphering the Role of Oxytocin in Motivation: an fMRI Study
Focus of Study: Neural Correlates of Oxytocin Administration
Bottom Line
View on ClinicalTrials.gov: NCT01722071 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcome: Primary: Functional Magnetic Resonance Imaging (fMRI) Data: Change in BOLD Activity Between Placebo and Oxytocin Treatment. — 0.7944; 0.5790; 0.6119; 0.6688 BOLD signal change (beta values) — p=0.890
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); Oxytocin (Drug)
- Age
- Adult · 20+ yrs
- Sex
- Male
- Sponsor
- Tiffany Love
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Functional Magnetic Resonance Imaging (fMRI) Data: Change in BOLD Activity Between Placebo and Oxytocin Treatment. |
0.7944; 0.5790; 0.6119; 0.6688 | 0.890 |
Summary
The proposed study will investigate the effects of intranasal oxytocin administration on neural activity associated with social and non-social motivation.
Eligibility Criteria
Inclusion Criteria
- Male
- 20-35 years of age at the time of screening
- Right-handedness
- Non-smoking
- No current or past history of neurological or psychiatric illness, including substance abuse or dependence
- No acute medical illness
- Written informed consent obtained from subject
Exclusion Criteria
- Female
- Left-handedness or ambidextrous
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
- Known allergies to oxytocin or to preservatives in the nasal spray
- Participants who exhibit nasal obstruction or upper-respiratory tract infection at the time of scanning or report the use of intranasally administered medications for up to two weeks prior to screening
- Participants unable to tolerate the scanning procedures or would be unfit for scanning purposes (e.g. metal implants, claustrophobic, unable to lie still for the duration of the scan)
- Any current or past history of medical, neurological, or psychiatric illness or family history of psychiatric or neurologic disease in first-degree relatives
- Neurological illness, abnormal MRI (except if due to technical factors)
- Acute or uncorrected medical illnesses, including history of hepatic or renal dysfunction.
- Participants currently taking medications including any treatment, current or past with antipsychotics, mood stabilizers, isoniazid, glucocorticoids, psychostimulants and psychostimulant appetite suppressants, or centrally active antihypertensive drugs (e.g., clonidine, reserpine).
- Treatment within six months with any of the following: hormone use (testosterone, DHEA), antidepressants, opioid drugs.
- Treatment within one month with sedative hypnotic medications (benzodiazepines, barbiturates), or over the counter sleeping aids
- Current or past history of substance abuse or dependence
- Any reported lifetime use of any category of illicit drugs
- Positive urine drug screen
Data sourced from ClinicalTrials.gov (NCT01722071). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.