Use of Intranasal Oxytocin During Detoxification of Crack Cocaine

NCT04306354 | Unknown Phase 1

• 2 other identifiers: U1111-1188-655539868314.0.0000.5336
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

crack cocaine; addiction; stimulants; oxytocin; detoxification; abstinence; withdrawal

Outcome Measures

Primary Outcomes (3)

• Withdrawal symptoms

  Change from baseline withdrawal symptoms (hospital admission) at the end of detoxification treatment (21 days) assessed by Cocaine Selective Severity Assessment (CSSA, minimum and maximum scores: 0 - 112). After treatment, the oxytocin-treated group is expected to have significantly lower withdrawal scores (better outcome) than the other groups (30%).

  Change from baseline (first week after hospital admission) at the end of detoxification treatment (21 days).

• Anxiety symptoms

  Change from baseline anxiety symptoms (hospital admission) at the end of detoxification treatment (21 days) assessed by the Patient-Reported Outcomes Measurement Information System Short Form scale (PROMIS, minimum and maximum raw scores: 8 - 40). After treatment, the oxytocin-treated group is expected to show lower anxiety scores (better outcome) compared to the other groups (30%).

  Change from baseline (first week after hospital admission) at the end of detoxification treatment (21 days).

• Depression symptoms

  Change from baseline depressive symptoms (hospital admission) at the end of detoxification treatment (21 days) assessed by the Quick Inventory of Depressive Symptomatology Self-Report scale (QIDS-SR, minimum and maximum scores: 0 - 27). After treatment, the oxytocin-treated group is expected to show lower depressive scores (better outcome) compared to the other groups (30%).

  Change from baseline (first week after hospital admission) at the end of detoxification treatment (21 days).

Secondary Outcomes (2)

• Neuroleptic Dose Change

  Change from baseline (first week after hospital admission) at the end of detoxification treatment (21 days)

• Adherence of outpatient treatment

  six months after hospital discharge

Study Arms (3)

Conventional oxytocin treatment (T + OC)

EXPERIMENTAL

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.

Drug: Oxytocin nasal spray

Conventional treatment with placebo administration (T + PBO)

PLACEBO COMPARATOR

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.

Drug: placebo nasal spray

Conventional treatment (T)

NO INTERVENTION

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.

Interventions

Oxytocin nasal spray DRUG

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

Conventional oxytocin treatment (T + OC)

placebo nasal spray DRUG

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.

Conventional treatment with placebo administration (T + PBO)

Eligibility Criteria

• Age: 18 Years - 52 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Volunteers (no payment to be enroll in the research according with Brazilian legislation)
• Age 18-52 years
• Primary diagnosis of cocaine crack dependence according to DSM-5
• Sex feminine
• Participants must be abstinent at least 7 days prior the study intervention
• Participants must consent to be randomly allocated to experimental conditions

You may not qualify if:

• Pregnancy
• Puerperium
• Breastfeeding
• Menopause
• Currently using hormone therapy
• 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
• Moderate or severe psychotic syndrome
• Obesity Level III
• Intellectual impairment (IQ \<70)
• Corticosteroid therapy, glucocorticoid or any exogenous steroid therapy
• Infectious condition or acute febrile syndrome
• Significant nasal congestion
• Type III nasal septum deviation (cases considered severe with deviated septum in which breathing is impaired)

Sponsors & Collaborators

• Pontificia Universidade Católica do Rio Grande do Sul: lead
• Secretaria Nacional de Políticas sobre Drogas (SENAD): collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Hospital Santa Ana

Porto Alegre, Rio Grande do Sul, 91720-440, Brazil

RECRUITING

MeSH Terms

Conditions

Cocaine Smoking; Cocaine-Related Disorders; Behavior, Addictive

Condition Hierarchy (Ancestors)

Smoking, Non-Tobacco Products; Smoking; Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior

Study Officials

• Rodrigo Grassi-Oliveira, MD, PhD

  Pontifícia Universidade Católica do Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rodrigo Grassi-Oliveira, MD, PhD

CONTACT

+555133203633; rodrigo.grassi@pucrs.br

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: On the eve of the eighth day of hospitalization, a person in charge of the research team performed a randomization of the participants exchanged in blocks, according to the methods of Schulz and collaborators (SCHULZ; GRIMES, 2002). The responsible person did not have contact with the participants. The blocks were made up of 12 participants each, and the ratio was maintained at 4: 4: 4, in order to reduce the chances of the groups getting mixed amounts. The members of the research team responsible for data collection, the technical team of the inpatient unit and the participants did not know to what condition each patient had been allocated. These procedures guaranteed the randomization and double blinding of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: March 12, 2020
• Study Start: September 15, 2018
• Primary Completion: April 30, 2020
• Study Completion: May 31, 2020
• Last Updated: March 12, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: By the time of publication
• Access Criteria: open access

Locations

BR (1)