Use of Intranasal Oxytocin During Detoxification of Crack Cocaine
Status:
Recruiting
Trial end date:
2020-05-31
Target enrollment:
Participant gender:
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 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
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Pontificia Universidade Católica do Rio Grande do Sul
Collaborators:
Conselho Nacional de Desenvolvimento Científico e Tecnológico Secretaria Nacional de Políticas sobre Drogas (SENAD)