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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

Primary Purpose

Opiate Dependence

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Oxytocin
Sponsored by
MacDonald, Kai, M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Opiate Dependence focused on measuring oxytocin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)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

Sites / Locations

  • UCSD Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

oxytocin

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 28, 2014
Last Updated
September 11, 2014
Sponsor
MacDonald, Kai, M.D.
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1. Study Identification

Unique Protocol Identification Number
NCT02052258
Brief Title
Oxytocin in Opiate Dependence: A Pilot Study of the Effects of Intranasal Oxytocin on Emotional Processes and Stress Responses in Patients With Opiate Dependence
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 Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MacDonald, Kai, M.D.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opiate Dependence
Keywords
oxytocin

7. Study Design

Study Phase
Phase 1

8. Arms, Groups, and Interventions

Arm Title
oxytocin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Primary Outcome Measure Information:
Title
Cold Pressor Task
Description
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.
Time Frame
up to 5 minutes

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nick Schaffner
Phone
619-543-6999
Facility Information:
Facility Name
UCSD Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nick Schaffner
First Name & Middle Initial & Last Name & Degree
Kaimana MacDonald, M.D.

12. IPD Sharing Statement

Learn more about this trial

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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