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Use of Intranasal Oxytocin during Detoxification of Crack/Cocaine

Protection targets to women crack users

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-383vcp
Enrollment
Unknown
Registered
2015-09-21
Start date
2016-11-05
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crack cocaine addiction

Interventions

Case Group: 20 female crack cocaine users will perform an experimental session with functional magnetic resonance imaging with cognitive tasks, followed by another experimental session with functional
or a dose of intranasal spray with placebo solution (only the vehicle used for intranasal oxytocin spray). The definition of which session (first or second) will inhale oxytocin or placebo will be ran
or a dose of intranasal spray with placebo solution (only the vehicle used for
Drug
Behavioural
HP3.073.433.101
N06.850.460.350.112

Sponsors

Conselho Nacional de Desenvolvimento Científico e Tecnológico - CNPq
Lead Sponsor
Departamento de Ciência e Tecnologia da Secretaria de Ciência, Tecnologia e Insumos Estratégicos
Collaborator
Secretaria Nacional de Políticas Sobre Drogas
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: For both groups: female; age 18-50 years; absence of menopause; with right-handed manual dominance; HIV-; no metals in the body; no recent tattoo (2 months), BHCG -; declare abstainers from non-tobacco drugs in the last 2 weeks; no evidence of claustrophobia, no history of eye, ear and brain surgery; no administration of benzodiazepines and neuroleptics in the last 24 hours; no history of head trauma, literate. For the control group: Declare no substance-related disorder. For the case group: Diagnosis of cocaine-related disorder (crack) according to the Diagnostic and Statistical Manual of Mental Disorders 5th edition.

Exclusion criteria

Exclusion criteria: Controls reporting on use of psychiatric medications; positive urine test for cocaine, benzodiazepine, amphentamine, opioids and alcohol; illiterate; Psychotic syndromes; have been pregnant for the past 6 months; have an IQ <70; neurological disease; metal prostheses; and / or tattoos or other metallic artifacts that make magnetic resonance imaging unfeasible. Possess claustrophobia; chronic respiratory disease; deviated septum type III; presence of lesions in the nasal mucosa; history of head injury; or currently have nasal congestion. Healthy group participants with ongoing mental disorders; crack users who have declared themselves abstinent for more than two months.

Design outcomes

Secondary

MeasureTime frame
Lower subjective craving for crack while watching crack cues measured by a visual analogic scale considering 5% of variation in the means under intranasal oxytocin use in comparison to placebo solution use.

Primary

MeasureTime frame
Increased prefrontal interhemispheric brain functional connectivity during resting-state measured by Voxel-Mirrored Homotopic Connectivity for interpretation of data from functional magnetic ressonance imaging exam considering 5% of variations between the means for intranasal oxytocin use and intranasal placebo solution use.

Countries

Brazil

Contacts

Public ContactRodrigo de Oliveira

Pontifícia Universidade Católica do Rio Grande do Sul

rodrigo.grassi@pucrs.br+55 (51) 3320 3633

Outcome results

None listed

Source: REBEC (via WHO ICTRP)