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

Description

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 Oxytocin could reduce relapse risk by reducing stress sensitivity. To measure the stress sensitivity, this study will evaluate a new stress challenge: a) Intranasal desmopressin, a vasopressin analog, will be used an endocrine stressor; its effects will be evaluated by serial measurements of serum Adrenocorticotropin hormone (ACTH), and self reports; b) if pretreatment with intranasal oxytocin dampens the ACTH and subjective response to intranasal desmopressin. These measures will be tested during a 7-day inpatient abstinence induction hospitalization. For those patients with family and work obligations, an outpatient abstinence induction procedure is available. The response to the desmopressin challenge will be compared to a cohort of matched control subjects. After abstinence induction, cocaine dependent patients enter a 6-week, double blind, randomized, placebo-controlled trial of 24 IU of intranasal oxytocin vs. placebo, to monitor if this reduces the relapse risk.

Study Start Date

March 2015

Estimated Completion Date

October 2016

Interventions

  • Drug: Placebo
  • Drug: Intranasal Oxytocin

Specialties

  • Psychiatry: Substance Abuse
  • Family Medicine: Substance Abuse
  • Pharmacy: Neuro/Psych pharmacology
  • Nurse Practitioner: Substance Abuse

MeSH Terms

  • Cocaine Dependence
  • Intranasal Oxytocin

Study ID

New York State Psychiatric Institute -- #6933

Status

Unknown

Trial ID

NCT02255357

Study Type

Interventional

Trial Phase

Phase 2/Phase 3

Enrollment Quota

150

Sponsor

New York State Psychiatric Institute

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. Substance Induced Mood Disorder with Hamilton Depression Scale ? 15 will be excluded. Patients with Major Depressive Disorder will be eligible to participate, provided they are in remission (Hamilton Depression Scale Score < 8), whether receiving treatment or not.
  • History of allergic, dermatological, 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: hypertension (>140/90), hepatitis (patients with chronic mildly elevated transaminase levels (?2-3 X upper limit of normal will be considered acceptable if PT/PTT is normal), serum sodium (Na) <133 mEq/L, renal failure (creat >2
  • BUN >40. History of hyponatremia. Patients on medication (Thiazide diuretics (hydrochorothiazide), Angiotensin Converting Enzyme (ACE) inhibitors, antidepressants, antipsychotics, anticonvulsants, medical use of desmopressin, NSAIDS) that may induce hyponatremia will not be excluded, provided no evidence of hyponatremia is found at screening.
  • 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 (control participants):
  • 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 (control participants):
  • DSM-IV Axis 1 psychiatric diagnosis. Patients with Major Depressive Disorder will be eligible to participate, provided they are in remission (Hamilton Depression Scale Score <8), whether receiving treatment or not.
  • Unstable physical disorders, which might make participation hazardous. Serum sodium (Na) <133 mEq/L, renal failure (creat >2, BUN >40) is exclusionary. Patients on medications (Thiazide diuretics (hydrochorothiazide), Angiotensin Converting Enzyme (ACE) inhibitors, antidepressants, antipsychotics, anticonvulsants, medical use of desmopressin, NSAIDS) that may cause hyponatremia will not be excluded, provided there is no evidence of hyponatremia at screening.
  • 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 allergic, dermatological, 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 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.
  • Gender

    Both

    Ages

    18 Years to 60 Years

    Accepts Healthy Volunteers

    Accepts Healthy Volunteers

    Study Locations and Contact Information (2)

    Study Location Distance Name Phone Email
    Substance Treatment and Research Service STARS - Manhattan, New York 44.8 miles Wilfrid N Raby PhD MD 212-740-7311 Rabywil@nyspi.columbia.edu
    Divison on Substance Abuse Albert Einstein College of Medicine - Bronx, New York 54.1 miles Sarah Church PhD 718-409-9450 schurch@dosa.aecom.yu.edu

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