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Status:

COMPLETED

Investigation of Intranasal Oxytocin on Relapse Risk in Cocaine-dependent Patients.

Lead Sponsor:

New York State Psychiatric Institute

Conditions:

Cocaine Dependence

Eligibility:

All Genders

18-60 years

Phase:

PHASE2

PHASE3

Brief Summary

This proposal describes a combined laboratory and clinical trial preliminary investigation to advance medication development for cocaine dependence. The main objective is to test whether intranasal Ox...

Detailed Description

This study is based on the findings that chronic stress, caused in these patients by cocaine dependence, increases the sensitivity of the Hypothalamo-Pituitary-Adrenal (HPA) axis and CNS stress pathwa...

Eligibility Criteria

Inclusion

  • Study Inclusion Criteria (cocaine-dependent participants):
  • Age 18 to 60.
  • Meet DSM-IV criteria for current cocaine dependence and is seeking treatment.
  • Displays at least one cocaine-positive urine toxicology during screening.
  • Use of cocaine at least 4 days in the past month, with at least weekly use, or reports episodic binges of large amounts of cocaine (at least $200) at least 2x/month.
  • Able to give informed consent and comply with study procedures.
  • Can pass the blindfolded scent test recognizing the scent of cinnamon or coffee.
  • Study Exclusion Criteria (cocaine-dependent participants):
  • Meets DSM-IV criteria for bipolar disorder, schizophrenia or any psychotic disorder other than transient psychosis due to drug abuse. Severe depression is an exclusion criteria (Hamilton Depression Scale ≥ 15).
  • History of allergy or adverse event related to Oxytocin or Desmopressin. Patient using Oxytocin or Vasopressin-based products cannot participate.
  • Chronic organic mental disorder, insufficient proficiency in English, or any condition or status (illiteracy) that would render an individual incapable of giving informed consent.
  • Significant current suicidal risk, suicide attempt within the past year.
  • Unstable physical disorders, which might make participation hazardous.
  • Coronary Vascular disease as indicated by history, or suspected by abnormal ECG.
  • Currently meets DSM-IV criteria for another substance dependence or abuse disorder other than nicotine, or alcohol. If alcohol dependent, must not be in need of detoxification.
  • Participants who cannot comply with study procedures during the inpatient or outpatient abstinence induction (phase 1) will not proceed to Phase 2.
  • Pregnancy, positive urine pregnancy test, or breastfeeding. Women who wish to participate must agree to use a method of contraception during the study and sign a written commitment to that effect, and submit to a urine pregnancy test every two weeks of Phase 2.
  • History of transphenoidal surgery or sinus surgery in the past month. Simple nasal congestion is not exclusionary.
  • Study Inclusion Criteria (healthy volunteers):
  • Age 18 to 60.
  • Able to give informed consent and comply with study procedures.
  • Can pass the blindfolded scent test recognizing the scent of cinnamon or coffee.
  • Study Exclusion Criteria (healthy volunteers):
  • DSM-IV Axis 1 psychiatric diagnosis. Severe Major Depression (Hamilton Depression Scale \> 15) is an exclusion criteria.
  • Unstable physical disorders, which might make participation hazardous.
  • Diagnosis of Substance Abuse or Dependence disorder, with exception of nicotine dependence. Patients in remission may participate if its duration is greater than 2 years preceding participation.
  • History of allergy or adverse event related to oxytocin or desmopressin. Patient using oxytocin or vasopressin-based products cannot participate.
  • Chronic organic mental disorder, insufficient proficiency in English or illiteracy that would render an individual incapable of giving informed consent.
  • History of transphenoidal surgery or sinus surgery in the past month. Simple nasal congestion is not exclusionary.

Exclusion

    Key Trial Info

    Start Date :

    March 1 2015

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    February 14 2018

    Estimated Enrollment :

    43 Patients enrolled

    Trial Details

    Trial ID

    NCT02255357

    Start Date

    March 1 2015

    End Date

    February 14 2018

    Last Update

    June 5 2023

    Active Locations (2)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (2 locations)

    1

    Substance Treatment and Research Service (STARS)

    Manhattan, New York, United States, 10032

    2

    Divison on Substance Abuse - Albert Einstein College of Medicine

    The Bronx, New York, United States, 10045