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Cocaine DependencePhase 2/3NCT02255357

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

A Phase 2/3 study testing Intranasal Oxytocin in people with Cocaine Dependence, run by New York State Psychiatric Institute at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Cocaine Dependence
What is being tested?
Intranasal Oxytocin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
43 participants
Where
2 sitesUnited States
Study dates
Mar 2015to 14 Feb 2018
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Substance Treatment and Research Service (STARS)

    Manhattan, New York, 10032

  • Divison on Substance Abuse - Albert Einstein College of Medicine

    The Bronx, New York, 10045

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Placebo, Intranasal Oxytocin
Keywords
Oxytocin, Vasopressin, Cocaine
Medical subject headings
Cocaine-Related Disorders, Diabetes Insipidus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

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

  • Intranasal OxytocinDrug

    Also called Syntocinon

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

Study groups in NCT02255357
Study groupRoleWhat they receive
PlaceboPlacebo comparatorSolution containing only the excipients of the original solution without Oxytocin.
Receives: Drug: Placebo
Intranasal SyntocinonActive comparatorIntranasal Oxytocin 24 IU per day.
Receives: Drug: Intranasal Oxytocin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Phase 1: 7 days; Phase 2: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2014 (estimated)
  2. Study startMar 2015
  3. Primary completion14 Feb 2018
  4. Study completion14 Feb 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02255357
Sponsor's protocol ID
#6933
Other IDs
DA035461-01A1
Status last verified
Jun 2023
First submitted
30 Sep 2014
Last updated
5 Jun 2023
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 17526941

  • 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.

    PubMed 18655903

  • 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.

    PubMed 19934046

  • 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.

    PubMed 15290695

  • 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.

    PubMed 9256988

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Intranasal Oxytocin in people with Cocaine Dependence, run by New York State Psychiatric Institute at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weeks of Abstinence From Cocaine (time frame: Phase 1: 7 days; Phase 2: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02255357, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023.

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