Use of Intranasal Oxytocin During Detoxification of Crack Cocaine

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

Conditions

• Cocaine Withdrawal
• Cocaine Smoking
• Cocaine-Related Disorders

Interventions

DRUG

Oxytocin nasal spray

Oxytocin nasal spray 24 UI twice daily as adjunctive treatment to conventional treatment during 10 days of detoxification of crack cocaine

DRUG

placebo nasal spray

Nasal spray with 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.

Sponsors & Collaborators

• Secretaria Nacional de Políticas sobre Drogas (SENAD)

  collaborator UNKNOWN

• Conselho Nacional de Desenvolvimento Científico e Tecnológico

  collaborator OTHER_GOV

• Pontificia Universidade Católica do Rio Grande do Sul

  lead OTHER

Principal Investigators

• Rodrigo Grassi-Oliveira, MD, PhD · Pontifícia Universidade Católica do Rio Grande do Sul

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

52 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-09-15

Primary Completion

2020-04-30

Completion

2020-05-31

Countries

• Brazil

Study Locations