NCT02028533已完成1 期
Chronic Intranasal Oxytocin as an Adjunct to Methadone Maintenance Treatment in Patients With Co-occuring Opioid Use Disorder and Cocaine Use: A 2-week Pilot Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of patients with non-serious and serious adverse events
研究概览
简要总结
This is a pilot feasibility study assessing the tolerability of chronic administration of intranasal oxytocin to patients receiving methadone at an opioid replacement clinic who are actively using cocaine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrolled as a patient in the San Francisco General Hospital Opioid Treatment Outpatient Program
- •Stable dose of methadone for at least the past two weeks
- •At least one routine urine toxicology screen positive for cocaine in the past month
排除标准
- •Positive urine pregnancy test
- •Use of illicit drugs in the past month (with the exception of cocaine or cannabis)
- •Currently meets Diagnostic and Statistical Manual-5 (DSM-V) criteria for severe major depressive disorder with suicidal thoughts or actions
- •History of psychotic or moderate-severe alcohol use disorder as defined by DSM-V criteria
- •Severe neuropsychological disorder, brain trauma, epilepsy
- •Sensitivity to preservatives (in particular E 216, E 218 and chlorobutanol hemihydrate)
- •Nasal obstruction, discharge, or bleeding
- •Habitually drinks large volumes of water
- •Taking testosterone, estrogen/progesterone supplement, or serotonin-1a receptor agonists/antagonists
研究组 & 干预措施
Patients 1
Active Comparator
Participants will receive intranasal oxytocin 40 International Units (IU).
干预措施: Oxytocin (Drug)
Patients 2
Placebo Comparator
Participants will receive 40 International Units of intranasal placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of patients with non-serious and serious adverse events
时间窗: 3 weeks
次要结局
未报告次要终点
研究者
Joshua Woolley
Principal Investigator
University of California, San Francisco
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Piloting Treatment With Intranasal Oxytocin in Phelan-McDermid SyndromePhelan-McDermid SyndromeNCT02710084Alexander Kolevzon18
进行中（未招募）
2 期
Intranasal Oxytocin for Frontotemporal DementiaFrontotemporal DementiaNCT03260920Lawson Health Research Institute112
终止
3 期
High Dose Oxytocin Nasal Spray for Treatment of TinnitusTinnitusNCT04210310NYU Langone Health33
已完成
2 期
Investigation of Intranasal Oxytocin on Relapse Risk in Cocaine-dependent Patients.Cocaine DependenceNCT02255357New York State Psychiatric Institute43
招募中
2 期
Intranasal Oxytocin Intervention for Caregivers to Persons With DementiaStressNCT06364228University of Nebraska32