Oxytocin in Opiate Dependence: A Pilot Study of the Effects of Intranasal Oxytocin on Emotional Processes and Stress Responses in Patients With Opiate Dependence
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ClinicalTrials.gov Identifier: NCT02052258
Recruitment Status : Unknown
Verified September 2014 by MacDonald, Kai, M.D.. Recruitment status was: Recruiting
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.
Oxytocin in Opiate Dependence: A Double-blind, Within-subjects, Placebo-controlled Pilot Study of the Effects of Intranasal Oxytocin on Emotional Processes and Stress Responses in Patients With Opiate Dependence
Study Start Date :
Estimated Primary Completion Date :
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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.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
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
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