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

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ClinicalTrials.gov Identifier: NCT02255357
Recruitment Status : Completed
First Posted : October 2, 2014
Results First Posted : November 29, 2019
Last Update Posted : November 29, 2019
Sponsor:
Information provided by (Responsible Party):
Wilfrid Raby, New York State Psychiatric Institute

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 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.

Condition or disease Intervention/treatment Phase
Cocaine Dependence Drug: Placebo Drug: Intranasal Oxytocin Phase 2 Phase 3

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 pathways to vasopressin. For their part, oxytocin systems, in chronic stress, acquire an increasing moderating effect on CNS stress system and the HPA axis. Cocaine dependence generates increased responsivity of stress system to oxytocin in the face of depleted oxytocin stores; thus creating an environment where exogenous oxytocin could exert a strong regulatory effect. Intranasal administration provides a convenient method to deliver these small peptides to the brain. Studying the feasibility of this approach, and its applicability to the treatment of cocaine-dependent patients, will be a goal of the study. The main outcome of this study will be the number of consecutive days of abstinence from cocaine after abstinence induction. A secondary outcome will be: Is the acute effect of intranasal oxytocin on desmopressin-induced ACTH secretion associated with the number of days of continued abstinence.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Investigation of the Effect of Intranasal Oxytocin on Relapse Risk in Cocaine-dependent Patients
Study Start Date : March 2015
Actual Primary Completion Date : February 14, 2018
Actual Study Completion Date : February 14, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
Placebo Comparator: Placebo
Solution containing only the excipients of the original solution without Oxytocin.
Drug: Placebo
Solution containing only the excipients of the original solution without Oxytocin.

Active Comparator: Intranasal Syntocinon
Intranasal Oxytocin 24 IU per day.
Drug: Intranasal Oxytocin
solution containing Oxytocin 6 IU/0.1cc or per puff is used in this arm
Other Name: Syntocinon




Primary Outcome Measures :
  1. Number of Consecutive Weeks of Abstinence From Cocaine After Abstinence Induction [ Time Frame: Up to 6 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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 ClinicalTrials.gov identifier (NCT number): NCT02255357


Locations
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United States, New York
Divison on Substance Abuse - Albert Einstein College of Medicine
Bronx, New York, United States, 10045
Substance Treatment and Research Service (STARS)
Manhattan, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
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Principal Investigator: Wilfrid N Raby, PhD, MD Division of Substance Abuse, Department of Psychiatry - Columbia university
  Study Documents (Full-Text)

Documents provided by Wilfrid Raby, New York State Psychiatric Institute:
Study Protocol  [PDF] September 29, 2014
Statistical Analysis Plan  [PDF] March 15, 2013

Additional Information:
Publications:
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Responsible Party: Wilfrid Raby, Principal Investigator, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT02255357    
Other Study ID Numbers: #6933
DA035461-01A1 ( Other Grant/Funding Number: NIDA )
First Posted: October 2, 2014    Key Record Dates
Results First Posted: November 29, 2019
Last Update Posted: November 29, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Wilfrid Raby, New York State Psychiatric Institute:
Oxytocin
Vasopressin
Cocaine
Additional relevant MeSH terms:
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Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs