Use of Intranasal Oxytocin During Detoxification of Crack Cocaine

NCT ID: NCT04306354

Last Updated: 2020-03-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-15
• Study Completion Date: 2020-05-31

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

Detailed Description

Design: Randomized treatment control trial, double-blind, parallel, with two arms.

Sample: Ninety-six hospitalized women between 18 and 52 years will participate in this study. 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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)
• Mucosal lesions
• History of head trauma moderate or severe (Glasgow <12)
• HIV +

Primary Outcome Measure:

1. 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%).

2. 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%).

3. 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%).

Secondary Outcome Measures:

1. Neuroleptic Dose Change Dose change of neuroleptic medications used during hospitalization for agitation or irritability (expected 25% lower).

2. Adherence of outpatient treatment Rate of adherence of outpatient treatment six months after discharge (expected to be 20% higher) assessed by reviewing the medical records of each patient within the outpatient program. If patient would be enrolled in the outpatient program after six months from detoxification she will be considered adhered to the program (higher rates means better outcome).

Conditions

Cocaine Withdrawal; Cocaine Smoking; Cocaine-Related Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Oxytocin nasal spray

Intervention Type: DRUG

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

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.

Group Type: PLACEBO_COMPARATOR

placebo nasal spray

Intervention Type: 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 (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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Oxytocin nasal spray

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

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)
• Mucosal lesions
• History of head trauma moderate or severe (Glasgow <12)
• HIV +

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 52 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Secretaria Nacional de Políticas sobre Drogas (SENAD)

UNKNOWN

Sponsor Role: collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role: collaborator

Pontificia Universidade Católica do Rio Grande do Sul

OTHER

Sponsor Role: lead

Responsible Party

Rodrigo Grassi-Oliveira

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rodrigo Grassi-Oliveira, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Pontifícia Universidade Católica do Rio Grande do Sul

Locations

Hospital Santa Ana

Porto Alegre, Rio Grande do Sul, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Rodrigo Grassi-Oliveira, MD, PhD

Role: CONTACT

rodrigo.grassi@pucrs.br

+555133203633

Facility Contacts

João Vitor Nobrega, MD

Role: primary

Other Identifiers

U1111-1188-6555

Identifier Type: REGISTRY

Identifier Source: secondary_id

39868314.0.0000.5336

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1188-6555

Identifier Type: -

Identifier Source: org_study_id