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Completed NCT04306354

Use of Intranasal Oxytocin During Detoxification of Crack Cocaine

Conditions: Cocaine Withdrawal, Cocaine Smoking, Cocaine-Related Disorders

Sex: Female
Ages: 18 Years – 52 Years
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 84
Sponsor: Pontificia Universidade Católica do Rio Grande do Sul

Location: Hospital Santa Ana Porto Alegre Rio Grande do Sul

Summary

This study investigated whether adding oxytocin nasal spray to usual inpatient treatment could reduce withdrawal, anxiety, and depressive symptoms in women hospitalized for cocaine detoxification. A total of 84 women were randomly assigned to one of three groups: usual treatment plus oxytocin nasal spray (30 participants), usual treatment plus placebo nasal spray (29 participants), or usual treatment alone (25 participants). Participants receiving a nasal spray and the staff administering it did not know whether it contained oxytocin or placebo. The usual-treatment-only group did not receive a nasal spray and was not masked. Symptoms were assessed during hospitalization, before, during, and after the intervention. Follow-up assessed relapse and duration of abstinence during the six months after discharge, using telephone contact with participants and family members and review of outpatient medical records. Outpatient treatment adherence was also a planned secondary outcome.

Eligibility Criteria

Inclusion Criteria: * Female participants aged 18 to 52 years. * Primary diagnosis of cocaine use disorder according to DSM-5 criteria. Other co-occurring substance use disorders were permitted, provided that cocaine was the primary drug of choice. * Abstinence from cocaine for at least seven days before the intervention. * Provision of informed consent and willingness to undergo random allocation to one of the study groups. Exclusion Criteria: * HIV-positive status. * Pregnancy, postpartum status, or breastfeeding. * Menopause. * Current moderate or severe psychotic syndrome. * Treatment with corticosteroids, synthetic glucocorticoids, or other exogenous hormone or steroid therapy. * Intellectual impairment, defined as an intelligence quotient below 70. * An infectious condition or acute febrile syndrome. * Diagnosed or suspected neurological disease or syndrome, including current or previous stroke, epilepsy, cancer, or neurodegenerative disease. * Diagnosed or suspected autoimmune disease or syndrome. * Diagnosed or suspected current decompensated or severe cardiovascular, pulmonary, renal, gastrointestinal, or endocrine disease. * History of moderate or severe traumatic brain injury, specified in the manuscript as a Glasgow Coma Scale score below 12. * Significant nasal congestion preventing intranasal administration. * Type III nasal septal deviation with impaired breathing. * Nasal mucosal lesions. * Class III obesity. * History of any hysterectomy or bilateral oophorectomy.

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Source: ClinicalTrials.gov (NCT04306354). StuddyBuddy aggregates publicly available trial information.