Randomized, Double-Blind, Placebo Controlled Study of Intranasal Oxytocin During Detoxification of Crack Cocaine
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Change in Cocaine Withdrawal Symptoms
研究概览
简要总结
This study investigated whether adding oxytocin nasal spray to usual inpatient treatment could reduce withdrawal, anxiety, and depressive symptoms in women hospitalized for cocaine detoxification.
A total of 84 women were randomly assigned to one of three groups: usual treatment plus oxytocin nasal spray (30 participants), usual treatment plus placebo nasal spray (29 participants), or usual treatment alone (25 participants). Participants receiving a nasal spray and the staff administering it did not know whether it contained oxytocin or placebo. The usual-treatment-only group did not receive a nasal spray and was not masked.
Symptoms were assessed during hospitalization, before, during, and after the intervention. Follow-up assessed relapse and duration of abstinence during the six months after discharge, using telephone contact with participants and family members and review of outpatient medical records. Outpatient treatment adherence was also a planned secondary outcome.
详细描述
This study investigated whether adjunctive intranasal oxytocin could improve symptom reduction during inpatient detoxification in women with cocaine use disorder. It was conducted in a tertiary inpatient unit in Porto Alegre, Brazil.
Eligible participants who provided informed consent were randomly allocated to conventional treatment plus intranasal oxytocin, conventional treatment plus intranasal placebo, or conventional treatment alone. The placebo comparison evaluated the additional effects of oxytocin, while the conventional-treatment-only group provided a reference for symptom changes during usual inpatient care.
All groups received conventional inpatient treatment, including psychosocial interventions, nutritional care, physical activity, nursing care, and psychopharmacotherapy as clinically indicated. The intranasal intervention was administered during a 10-day period beginning on hospital day 8.
Participants and personnel administering the nasal spray were blinded to oxytocin versus placebo assignment. The conventional-treatment-only group received no nasal spray and was not masked.
Withdrawal and depressive symptoms were evaluated before, during, and after the intervention. The assessment windows were hospital days 1-4 for T1, days 8-11 for T2, and days 18-21 for T3. For participants receiving oxytocin or placebo, the final assessment was scheduled at least 24 hours after the last spray administration. Withdrawal symptoms were assessed using the Cocaine Selective Severity Assessment (CSSA), and depressive symptoms using the Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR). Anxiety symptoms were also assessed using the PROMIS anxiety short form, as specified in the registered outcomes.
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
Participants receiving intranasal treatment, personnel administering the nasal spray, and the investigator were blinded to oxytocin versus placebo assignment. The placebo contained the same vehicle as the oxytocin formulation, with propolis essence added for odor matching. Treatment assignments were unblinded at the end of the study by a postdoctoral researcher who was not otherwise involved in the project.
The conventional-treatment-only group received no nasal spray and was not masked.
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
- •Female participants aged 18 to 52 years.
- •Primary diagnosis of cocaine use disorder according to DSM-5 criteria. Other co-occurring substance use disorders were permitted, provided that cocaine was the primary drug of choice.
- •Abstinence from cocaine for at least seven days before the intervention.
- •Provision of informed consent and willingness to undergo random allocation to one of the study groups.
排除标准
- •HIV-positive status.
- •Pregnancy, postpartum status, or breastfeeding.
- •Menopause.
- •Current moderate or severe psychotic syndrome.
- •Treatment with corticosteroids, synthetic glucocorticoids, or other exogenous hormone or steroid therapy.
- •Intellectual impairment, defined as an intelligence quotient below
- •An infectious condition or acute febrile syndrome.
- •Diagnosed or suspected neurological disease or syndrome, including current or previous stroke, epilepsy, cancer, or neurodegenerative disease.
- •Diagnosed or suspected autoimmune disease or syndrome.
- •Diagnosed or suspected current decompensated or severe cardiovascular, pulmonary, renal, gastrointestinal, or endocrine disease.
- •History of moderate or severe traumatic brain injury, specified in the manuscript as a Glasgow Coma Scale score below
- •Significant nasal congestion preventing intranasal administration.
- •Type III nasal septal deviation with impaired breathing.
- •Nasal mucosal lesions.
- •Class III obesity.
- •History of any hysterectomy or bilateral oophorectomy.
研究组 & 干预措施
Conventional Treatment Plus Intranasal Placebo (PBO)
Participants received intranasal placebo in addition to conventional inpatient treatment. Each administration consisted of six sprays of placebo solution, given twice daily from hospital day 8 through day 17, for 10 days. The placebo contained the same vehicle as the oxytocin formulation, with 2% propolis essence added for odor matching.
Conventional treatment included individual and group supportive psychotherapy, nutritional care, regular physical activity, nursing care, and psychopharmacotherapy as clinically indicated to manage withdrawal-related symptoms. The planned inpatient treatment period was 21 days.
干预措施: placebo nasal spray (Drug)
Conventional Treatment Alone (CON)
Participants received conventional inpatient treatment alone, without intranasal oxytocin or placebo. Conventional treatment included individual and group supportive psychotherapy once weekly, nutritional care, regular physical activity, nursing care, and psychopharmacotherapy as clinically indicated to manage withdrawal-related symptoms, including anxiety, aggression, and agitation. The planned inpatient treatment period was 21 days.
干预措施: Conventional Inpatient Treatment (Other)
Conventional Treatment Plus Intranasal Oxytocin (OXT)
Participants received intranasal oxytocin in addition to conventional inpatient treatment. Each administration consisted of six sprays containing 4 IU each (24 IU per administration), given twice daily for a total daily dose of 48 IU. Treatment was administered from hospital day 8 through day 17, for 10 days.
Conventional treatment included individual and group supportive psychotherapy, nutritional care, regular physical activity, nursing care, and psychopharmacotherapy as clinically indicated to manage withdrawal-related symptoms. The planned inpatient treatment period was 21 days.
干预措施: Oxytocin nasal spray (Drug)
结局指标
主要结局
Change in Cocaine Withdrawal Symptoms
时间窗: Baseline (first week after hospital admission) and end of inpatient detoxification (up to hospital day 21).
Change from baseline to the end of inpatient detoxification in the Cocaine Selective Severity Assessment (CSSA) total score. Total scores range from 0 to 112, with higher scores indicating greater withdrawal symptom severity. Change is calculated as the end-of-treatment score minus the baseline score; negative values indicate improvement.
Change in Anxiety Symptoms
时间窗: Baseline (first week after hospital admission) and end of inpatient detoxification (up to hospital day 21).
Change from baseline to the end of inpatient detoxification in the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form raw total score. Raw total scores range from 8 to 40, with higher scores indicating greater anxiety symptom severity. Change is calculated as the end-of-treatment score minus the baseline score; negative values indicate improvement.
Change in Depressive Symptoms
时间窗: Baseline (first week after hospital admission) and end of inpatient detoxification (up to hospital day 21).
Change from baseline to the end of inpatient detoxification in the Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR) total score. Total scores range from 0 to 27, with higher scores indicating greater depressive symptom severity. Change is calculated as the end-of-treatment score minus the baseline score; negative values indicate improvement.
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
- Percentage of Participants Enrolled in Outpatient Treatment at Six Months(Six months after hospital discharge.)
- 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