Oxytocin in Opiate Dependence: A Pilot Study of the Effects of Intranasal Oxytocin on Emotional Processes and Stress Responses in Patients With Opiate Dependence

NCT02052258 | Unknown Phase 1

• 1 other identifier: 120283
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

oxytocin

Outcome Measures

Primary Outcomes (1)

• Cold Pressor Task

  The Cold Pressure task involves placing a hand or forearm in cold water, a stimulus that produces a slowly mounting pain of mild to moderate intensity and is terminated by voluntary withdrawal of the limb. The cold pressor task has been used in many studies of pain, autonomic reactivity, and hormonal stress responses.

  up to 5 minutes

Study Arms (1)

oxytocin

EXPERIMENTAL

Drug: Oxytocin

Interventions

Oxytocin DRUG

oxytocin

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MacDonald, Kai, M.D.: lead

Study Sites (1)

UCSD Medical Center

San Diego, California, 92103, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

Nick Schaffner

CONTACT

619-543-6999

Study Design

• Study Type: interventional
• Phase: phase 1
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2014
• First Posted: February 3, 2014
• Study Start: January 1, 2013
• Primary Completion: December 1, 2015
• Last Updated: September 15, 2014

Record last verified: 2014-09

Locations

US (1)