Randomized, Double-Blind, Placebo Controlled Study of Intranasal Oxytocin During Detoxification of Crack Cocaine
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Withdrawal symptoms
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 52 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: Oxytocin nasal spray (Drug)
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.
干预措施: placebo nasal spray (Drug)
结局指标
主要结局
Withdrawal symptoms
时间窗: Change from baseline (first week after hospital admission) at the end of detoxification treatment (21 days).
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%).
Anxiety symptoms
时间窗: Change from baseline (first week after hospital admission) at the end of detoxification treatment (21 days).
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%).
Depression symptoms
时间窗: Change from baseline (first week after hospital admission) at the end of detoxification treatment (21 days).
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%).
次要结局
- Adherence of outpatient treatment(six months after hospital discharge)
- Neuroleptic Dose Change(Change from baseline (first week after hospital admission) at the end of detoxification treatment (21 days))
研究者
Rodrigo Grassi-Oliveira
Professor
Pontificia Universidade Católica do Rio Grande do Sul