Recruiting
Phase 1

Oxytocin

Sponsor:

MacDonald, Kai, M.D.

Code:

NCT02052258

Conditions

Opiate Dependence

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Oxytocin

Study Details

Brief summary:

Opiate dependence is a serious problem, and oxytocin has many properties which make it attractive as a treatment for this type of substance dependence. This experiment will test the effects of oxytocin on a variety of brain-based processes in patients with opiate dependence. The investigators hypothesize that intranasal oxytocin in these conditions will enhance emotional processing and will have beneficial effects on stress responses in opiate-dependent patients.

Conditions

Opiate Dependence

Study ID

NCT02052258

Start date

Jan, 2013

Status verified date

Sep, 2014

Primary completion date

Dec, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • adult men 18 years or older
  • meet DSM-IV criteria for opiate dependence, and no other active substance dependence disorder save nicotine dependence
  • clinically stable, and low risk for suicide as determined by principal investigator and screening questionnaire
  • abstinent from non-prescribed opiate use for at least two weeks from Baseline 1 and free from opiate withdrawal symptoms. If on agonist therapy, dose must be stable for 2 weeks before study visit.
  • must be able to use nasal spray
  • negative salivary drug screen, save for opiates

Exclusion Criteria:

  • any active medical condition that in the opinion of the investigator will interfere with the objectives of the study
  • any active, severe mental illness, neurological disorder, including schizophrenia, autism, Asperger's syndrome
  • are unsuitable in any way to participate in this study, in the opinion of the investigator
  • hospitalizations due to complications of an Axis 1 disorder for the past 12 months, excluding drug or alcohol rehabilitation
  • any clinically significant chronic pain condition, as determined by the principal investigator
  • positive salivary drug screen at the time of the visit, for any substance other than opiates or another prescribed medication

Study Design

Interventions and Outcome Measures

Arms

experimental: oxytocin

Interventions

Oxytocin

Primary outcome measure

  • Cold Pressor Task [ Time Frame: up to 5 minutes ]

Central Contacts and Locations

Central contacts

Nick Schaffner

619-543-6999

Locations

UCSD Medical Center

Recruiting

San Diego, California, United States, 92103

Principal Investigator:

Kaimana MacDonald, M.D.

More Information

Sponsor

MacDonald, Kai, M.D.

Last update posted

Sep 15, 2014

Last verified

Sep, 2014

Keywords

  • oxytocin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by MacDonald, Kai, M.D. on 2014-09-15.