Investigation of Intranasal Oxytocin on Relapse Risk in Cocaine-dependent Patients.
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

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.
    

Intervention name(s): Placebo; Intranasal Oxytocin
Intervention type(s): Drug; Drug
Intervention description(s): Solution containing only the excipients of the original solution without Oxytocin.; solution containing Oxytocin 6 IU/0.1cc or per puff is used in this arm
Other intervention name(s): Syntocinon
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Oxytocin; Vasopressin; Cocaine