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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02052258
Recruitment Status : Unknown
Verified September 2014 by MacDonald, Kai, M.D..
Recruitment status was:  Recruiting
First Posted : February 3, 2014
Last Update Posted : September 15, 2014
Information provided by (Responsible Party):
MacDonald, Kai, M.D.

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.

Condition or disease Intervention/treatment Phase
Opiate Dependence Drug: Oxytocin Phase 1

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Study Type : Interventional  (Clinical Trial)
Official Title: 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 : January 2013
Estimated Primary Completion Date : December 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
Experimental: oxytocin Drug: Oxytocin

Primary Outcome Measures :
  1. Cold Pressor Task [ Time Frame: up to 5 minutes ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02052258

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Contact: Nick Schaffner 619-543-6999

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United States, California
UCSD Medical Center Recruiting
San Diego, California, United States, 92103
Contact: Nick Schaffner         
Principal Investigator: Kaimana MacDonald, M.D.         
Sponsors and Collaborators
MacDonald, Kai, M.D.

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Responsible Party: MacDonald, Kai, M.D. Identifier: NCT02052258    
Other Study ID Numbers: 120283
First Posted: February 3, 2014    Key Record Dates
Last Update Posted: September 15, 2014
Last Verified: September 2014
Keywords provided by MacDonald, Kai, M.D.:
Additional relevant MeSH terms:
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Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Opiate Alkaloids
Reproductive Control Agents
Physiological Effects of Drugs
Analgesics, Opioid
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents