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COMPLETED
NCT04306354
PHASE1/PHASE2

Use of Intranasal Oxytocin During Detoxification of Crack Cocaine

Sponsor: Pontificia Universidade Católica do Rio Grande do Sul

View on ClinicalTrials.gov

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.

Official title: Randomized, Double-Blind, Placebo Controlled Study of Intranasal Oxytocin During Detoxification of Crack Cocaine

Key Details

Gender

FEMALE

Age Range

18 Years - 52 Years

Study Type

INTERVENTIONAL

Enrollment

84

Start Date

2018-09-17

Completion Date

2020-07-14

Last Updated

2026-09-28

Healthy Volunteers

No

Interventions

DRUG

Oxytocin nasal spray

Intranasal oxytocin was administered as six sprays containing 4 IU each (24 IU per administration), twice daily, for a total daily dose of 48 IU. Treatment was given from hospital day 8 through day 17, for 10 days, as an adjunct to conventional inpatient treatment.

DRUG

placebo nasal spray

Intranasal placebo was administered as six sprays twice daily from hospital day 8 through day 17, for 10 days, as an adjunct to conventional inpatient treatment. The placebo contained the same vehicle as the oxytocin formulation, with 2% propolis essence added for odor matching.

OTHER

Conventional Inpatient Treatment

Conventional inpatient treatment included individual and group supportive psychotherapy once weekly, nutritional care, regular physical activity, nursing care, and psychopharmacotherapy as clinically indicated to manage withdrawal-related symptoms, including anxiety, aggression, and agitation. The planned inpatient treatment period was 21 days.

Locations (1)

Hospital Santa Ana

Porto Alegre, Rio Grande do Sul, Brazil