Primary outcomeMean· Phase 1: 7 days; Phase 2: 6 weeks
Weeks of Abstinence From Cocaine
| Group | Value (weeks) |
|---|---|
| Placebo for Phase 2, Clinical Trial | 1.0 |
| Intranasal Syntocinon for Clinical Trial Phase 2 | 1.0 |
Trial · Interventional
CompletedPhase 2/3Results postedRegistry dataInvestigation of Intranasal Oxytocin on Relapse Risk in Cocaine-dependent Patients.
Overview
- Status
- Completed
- Phase
- Phase 2/3
- Enrollment
- 43 participants (actual)
- Sponsor
- New York State Psychiatric Institute · Other
- Design
- Randomized · Double masking
- Countries
1 country
United States
- Start
- Mar 2015
- Primary completion
- 14 Feb 2018
- Completion
- 14 Feb 2018
- First posted
- 2 Oct 2014 (estimated)
- Last update posted
- 5 Jun 2023
- Conditions
- Cocaine Dependence
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
20152016201720182019
- Ph 2/3
Investigation of Intranasal Oxytocin on Relapse Risk in Cocaine-dependent Patients.
NCT02255357Mar 2015 to 14 Feb 2018
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- PlaceboDrug
- Intranasal OxytocinDrug
Arms2
Placebo comparator
Placebo
Solution containing only the excipients of the original solution without Oxytocin.
Active comparator
Intranasal Syntocinon
Intranasal Oxytocin 24 IU per day.
Primary outcomes1
Outcomes the sponsor listed as primary.
Weeks of Abstinence From Cocaine
Time frame · Phase 1: 7 days; Phase 2: 6 weeks
Registry description
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
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| PlaceboSolution containing only the excipients of the original solution without Oxytocin. Placebo: Solution containing only the excipients of the original solution without Oxytocin. | 0 / 11 | 0 / 11 | 6 / 11 |
| Intranasal SyntocinonIntranasal Oxytocin 24 IU per day. Intranasal Oxytocin: solution containing Oxytocin 6 IU/0.1cc or per puff is used in this arm | 0 / 15 | 0 / 15 | 5 / 15 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies2
Studies that cite this trial.
More studies
2 studies on this page
PubMed tag: none · 2009
Oxytocin receptor genetic variation relates to empathy and stress reactivity in humans.
Rodrigues et al. 2009Proceedings of the National Academy of Sciences of the United States of Americacited by 474
PMID 19934046PMC2795557DOI 10.1073/pnas.0909579106PUB-19934046
Rights unknown
Indexing hint: Review · 2008
Peptide and non-peptide agonists and antagonists for the vasopressin and oxytocin V1a, V1b, V2 and OT receptors: research tools and potential therapeutic agents.
Manning et al. 2008Progress in brain researchcited by 206
PMID 18655903DOI 10.1016/s0079-6123(08)00437-8PUB-18655903
Full text at the publisher
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 60 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
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.
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