Mental and behavioural disorders due to use of cocaine
Conditions
Interventions
Ninety-six hospitalized women between 18 and 52 years will participate in this study. Those who agree to participate in the study and meet the eligibility criteria will be randomly allocated to one of
Drug
Behavioural
HP3.073.433.101
G09.772.770.755.700.390
Sponsors
Secretaria Nacional de Políticas Sobre Drogas
Conselho Nacional de Desenvolvimento Científico e Tecnológico - CNPq
Eligibility
Sex/Gender
Female
Age
18 Years to 52 Years
Inclusion criteria
Inclusion criteria: Volunteers; aged 18-52 years; with primary diagnosis of cocaine crack dependence according to DSM-5; female; participants must be abstinent at 7 days prior to the start of the intervention; participants must consent to be randomly allocated to experimental conditions.
Exclusion criteria
Exclusion criteria: Being pregnant; puerperal or nursing or menopausal; currently using hormone therapy; women who have had 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; have moderate or severe psychotic syndrome; level III obese women; presence of intellectual impairment (IQ <70); women receiving corticosteroid therapy, glucocorticoid or any exogenous steroid therapy; women with an infectious condition or acute febrile syndrome; have significant nasal congestion; have type III nasal septum deviation (cases considered severe with deviated septum in which breathing is impaired); have mucosal lesions; have a history of head trauma moderate or severe (Glasgow <12); HIV +.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Withdrawal symptoms assessed by Cocaine Selective Severity Assessment (CSSA) every 7 days over 21 days of cocaine detoxification. After treatment, the oxytocin-treated group is expected to have significantly lower withdrawal symptom rates than the other groups (30%).;Anxiety symptoms assessed by the PROMIS Anxiety Short Form scale every 7 days over 21 days of cocaine detoxification. After treatment, the oxytocin-treated group is expected to show decreased anxiety symptoms compared to the other groups (30%).;Depression symptoms assessed by the Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR) scale - every 7 days over 21 days of cocaine detoxification. After treatment, the oxytocin-treated group is expected to show decreased anxiety symptoms compared to the other groups (30%). After treatment, the oxytocin-treated group is expected to show decreased anxiety symptoms compared to the other groups (30%). | — |
Secondary
| Measure | Time frame |
|---|---|
| Dose reduction of neuroleptic medications used during hospitalization for agitation or irritability (25%);Maintenance of outpatient treatment six months after discharge (20%) | — |
Countries
Brazil
Contacts
Public ContactRodrigo Grassi-Oliveira
Pontifícia Universidade Católica do Rio Grande do Sul
Outcome results
None listed