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

NCT02255357 | Completed Phase 2 Results DMC

• 2 other identifiers: #6933DA035461-01A1
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 2

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.

Conditions

Cocaine Dependence

Keywords

Oxytocin; Vasopressin; Cocaine

Outcome Measures

Primary Outcomes (1)

• Weeks of Abstinence From Cocaine

  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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Solution containing only the excipients of the original solution without Oxytocin.

Drug: Placebo

Intranasal Syntocinon

ACTIVE COMPARATOR

Intranasal Oxytocin 24 IU per day.

Drug: Intranasal Oxytocin

Interventions

Placebo DRUG

Solution containing only the excipients of the original solution without Oxytocin.

Placebo

Intranasal Oxytocin DRUG

solution containing Oxytocin 6 IU/0.1cc or per puff is used in this arm

Also known as: Syntocinon

Intranasal Syntocinon

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (2)

Substance Treatment and Research Service (STARS)

Manhattan, New York, 10032, United States

Location

Divison on Substance Abuse - Albert Einstein College of Medicine

The Bronx, New York, 10045, United States

Location

Related Publications (5)

• Araya AV, Rojas P, Fritsch R, Rojas R, Herrera L, Rojas G, Gatica H, Silva H, Fiedler JL. Early response to venlafaxine antidepressant correlates with lower ACTH levels prior to pharmacological treatment. Endocrine. 2006 Dec;30(3):289-98. doi: 10.1007/s12020-006-0007-2.

  PMID: 17526941 BACKGROUND

• Manning M, Stoev S, Chini B, Durroux T, Mouillac B, Guillon G. Peptide and non-peptide agonists and antagonists for the vasopressin and oxytocin V1a, V1b, V2 and OT receptors: research tools and potential therapeutic agents. Prog Brain Res. 2008;170:473-512. doi: 10.1016/S0079-6123(08)00437-8.

  PMID: 18655903 BACKGROUND

• Rodrigues SM, Saslow LR, Garcia N, John OP, Keltner D. Oxytocin receptor genetic variation relates to empathy and stress reactivity in humans. Proc Natl Acad Sci U S A. 2009 Dec 15;106(50):21437-41. doi: 10.1073/pnas.0909579106. Epub 2009 Nov 23.

  PMID: 19934046 BACKGROUND

• Suzuki Y, Yamamoto S, Umegaki H, Onishi J, Mogi N, Fujishiro H, Iguchi A. Smell identification test as an indicator for cognitive impairment in Alzheimer's disease. Int J Geriatr Psychiatry. 2004 Aug;19(8):727-33. doi: 10.1002/gps.1161.

  PMID: 15290695 BACKGROUND

• Weiss RD, Griffin ML, Hufford C, Muenz LR, Najavits LM, Jansson SB, Kogan J, Thompson HJ. Early prediction of initiation of abstinence from cocaine. Use of a craving questionnaire. Am J Addict. 1997 Summer;6(3):224-31.

  PMID: 9256988 BACKGROUND

Related Links

• Oxytocin description
• Desmopressin Acetate description

MeSH Terms

Conditions

Cocaine-Related Disorders; Diabetes Insipidus

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: wilfrid raby, m.d.
• Organization: new york psychiatric institute

wilfrid.raby@nyspi.columbia.edu

2129233031

Study Officials

• Wilfrid N Raby, PhD, MD

  Division of Substance Abuse, Department of Psychiatry - Columbia university

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 30, 2014
• First Posted: October 2, 2014
• Study Start: March 1, 2015
• Primary Completion: February 14, 2018
• Study Completion: February 14, 2018
• Last Updated: June 5, 2023
• Results First Posted: November 29, 2019

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)