Status:
UNKNOWN
Use of Intranasal Oxytocin During Detoxification of Crack Cocaine
Lead Sponsor:
Pontificia Universidade Católica do Rio Grande do Sul
Collaborating Sponsors:
Secretaria Nacional de Políticas sobre Drogas (SENAD)
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Conditions:
Cocaine Withdrawal
Cocaine Smoking
Eligibility:
FEMALE
18-52 years
Phase:
PHASE1
PHASE2
Brief Summary
Randomized treatment control trial, double-blind, parallel, with two arms including ninety-six hospitalized women between 18 and 52 years. Those who agree to participate in the study and meet the elig...
Detailed Description
Design: Randomized treatment control trial, double-blind, parallel, with two arms. Sample: Ninety-six hospitalized women between 18 and 52 years will participate in this study. Those who agree to par...
Eligibility Criteria
Inclusion
- Volunteers (no payment to be enroll in the research according with Brazilian legislation)
- Age 18-52 years
- Primary diagnosis of cocaine crack dependence according to DSM-5
- Sex feminine
- Participants must be abstinent at least 7 days prior the study intervention
- Participants must consent to be randomly allocated to experimental conditions
Exclusion
- Pregnancy
- Puerperium
- Breastfeeding
- Menopause
- Currently using hormone therapy
- Total hysterectomy
- Diagnosis or suspicion of autoimmune or neurological diseases and / or syndromes (stroke, Parkinson and Alzheimer's)
- Diagnosis or suspected current decompensated and / or severe endocrine, cardiovascular, pulmonary, renal, gastrointestinal disorders
- Moderate or severe psychotic syndrome
- Obesity Level III
- Intellectual impairment (IQ \<70)
- Corticosteroid therapy, glucocorticoid or any exogenous steroid therapy
- Infectious condition or acute febrile syndrome
- Significant nasal congestion
- Type III nasal septum deviation (cases considered severe with deviated septum in which breathing is impaired)
- Mucosal lesions
- History of head trauma moderate or severe (Glasgow \<12)
- HIV +
Key Trial Info
Start Date :
September 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2020
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT04306354
Start Date
September 15 2018
End Date
May 31 2020
Last Update
March 12 2020
Active Locations (1)
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1
Hospital Santa Ana
Porto Alegre, Rio Grande do Sul, Brazil, 91720-440