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

June 2, 2023 updated by: Wilfrid Raby, New York State Psychiatric Institute

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
43

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10045
        • Divison on Substance Abuse - Albert Einstein College of Medicine
      • Manhattan, New York, United States, 10032
        • Substance Treatment and Research Service (STARS)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • Syntocinon

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Weeks of Abstinence From Cocaine
Time Frame: Phase 1: 7 days; Phase 2: 6 weeks

this is outcome for the phase 2, clinicial trial portion of this combined laboratory and clinical trial laboratory human study

For the human laboratory study, Phase 1, the primary outcome is differences in ACTH levels following a) Intranasal Desmopressin, and, on a consecutive day, b) Intranasal Desmopressin preceded by a treatment with Intranasal Oxytocin (Syntocinon). this takes place on 2 consecutive days
Phase 1: 7 days; Phase 2: 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
New York State Psychiatric Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Wilfrid N Raby, PhD, MD, Division of Substance Abuse, Department of Psychiatry - Columbia university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 14, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 14, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 30, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 2, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • #6933
  • DA035461-01A1 (Other Grant/Funding Number: NIDA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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