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Use of Intranasal Oxytocin During Detoxification of Crack Cocaine
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 eligibility criteria will be randomly allocated to one of the following experimental conditions: * Conventional oxytocin treatment (T + OC): 32 female cocaine users hospitalized for detoxification will receive six 4 IU jets of intranasal oxytocin twice daily (daily dose of 48 IU) as adjunctive treatment to conventional treatment from the eighth to seventeenth day of hospitalization (duration of oxytocin treatment of 10 days). Conventional treatment includes supportive individual and group psychotherapy (once a week), nutritional control, regular physical activity and psychopharmacotherapy as needed to relieve the symptoms of anxiety, aggression and agitation typical of withdrawal and care. 21 days of hospitalization. * Conventional treatment with placebo administration (T + PBO): 32 female cocaine users hospitalized for detoxification will receive six jets of placebo solution (2% odor-generating propolis essence + the same vehicle as intra-nasal oxytocin: 0.05% citric acid, 0.9% sodium chloride, 1% glycerol, 0.54% disodium phosphate, 0.2% methylparaben + propylparaben, 1% sorbitol, 80% water) twice daily as adjunctive treatment to conventional treatment from the eighth to the seventeenth day of hospitalization (duration of placebo treatment of 10 days). Conventional treatment includes supportive individual and group psychotherapy (once a week), nutritional control, regular physical activity and psychopharmacotherapy as needed to relieve the symptoms of anxiety, aggression and agitation typical of withdrawal and care. 21 days of hospitalization. * Conventional treatment (T): 32 female cocaine users hospitalized for detoxification will receive conventional treatment including individual and group supportive psychotherapy (once a week), nutritional control, regular physical activity and psychopharmacotherapy if needed for symptom relief. anxiety, aggression and agitation, typical of abstinence and nursing care, during 21 days of hospitalization. Outcomes: Withdrawal symptoms, Anxiety symptoms and Depressive symptoms
Details
| Lead sponsor | Pontificia Universidade Católica do Rio Grande do Sul |
|---|---|
| Phase | PHASE1, PHASE2 |
| Status | UNKNOWN |
| Enrolment | 96 |
| Start date | Sat Sep 15 2018 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Sun May 31 2020 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Cocaine Withdrawal
- Cocaine Smoking
- Cocaine-Related Disorders
Interventions
- Oxytocin nasal spray
- placebo nasal spray
Countries
Brazil