Investigation of Intranasal Oxytocin on Relapse Risk in Cocaine-dependent Patients.
Status:
Completed
Trial end date:
2018-02-14
Target enrollment:
Participant gender:
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.