Oxytocin Treatment of Opioid Dependence
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Area Under the Curve (AUC) in COWS Total Score on Days 1 to 5 Inclusive
研究概览
简要总结
Purpose: The purpose of this research study is to learn whether oxytocin treatment decreases use of and cravings for opioids (narcotics) in people who have been using opioids heavily for long periods of time and are unable to stop on their own.
Participants: Patients meeting DSM-IV-TR criteria for opioid dependence.
Procedures (methods): Subjects will have standard medications available for withdrawal symptoms from opioids and standard psychosocial interventions available in the inpatient setting. In addition, subjects will self-administer intranasal test treatments 3 times daily.
详细描述
The purpose of this research study is to learn whether oxytocin treatment decreases use of and cravings for opioids (narcotics) in people who have been using opioids heavily for long periods and are unable to stop on their own. Oxytocin is made naturally and is released in parts of the brain where it acts like a chemical signal from one cell to another. Oxytocin is approved by the Food and Drug Administration for stimulating labor in pregnant women but is not approved as a treatment for opioid dependence.
People who use large amounts of opioids every day or many days per week for weeks or months undergo chemical changes in their brains. They continue to use opioids frequently and heavily because, even though they may know opioid use is not good for their health, they have unpleasant experiences if they stop or decrease the amount used. Those experiences can include increased anxiety, difficulty sleeping, difficulty tolerating stress, and a craving to use opioids, as well as physical symptoms of withdrawal such as feeling sweaty or having chills, bone or joint aches, muscle cramps, nausea, diarrhea. Studies have shown that giving oxytocin to opioid-addicted animals diminished opioid use after they had been denied access to opioids for a while and reduced symptoms when they were put into opioid withdrawal.
This is a randomized, double-blind, Placebo-controlled trial in subjects with opioid dependence that will test the efficacy of intranasal Oxytocin (OT) treatment vs. Placebo (containing the same ingredients as the OT spray except OT) on:
- reducing opioid withdrawal symptoms and
- the total amount of standard, as needed (PRN) medications required to control withdrawal symptoms during medical opioid detoxification.
Treatment assignments will be random within each sex. Each treatment group will be composed of up to 25 subjects. Essentially, this study involves adding daily OT or Placebo administration on a fixed schedule onto standard symptom triggered treatment of opioid withdrawal using non-opioid medications.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Regular opioid use (daily or nearly daily) for at least 6 months (subjective report).
- •Active DSM-IV diagnosis of opioid dependence.
排除标准
- •Meets DSM-IV criteria for dependence on psychoactive substances other than opioids, caffeine or nicotine within 6 months prior to screening.
- •Treatment with naltrexone in the last month.
- •History of a significant psychiatric illness including: lifetime history of mania requiring hospitalization, psychotic disorder, cognitive disorder; history during the last two years of eating disorder. Standing or as needed non-exclusionary medications for non-exclusionary psychiatric disorders will be permitted.
- •Unstable medical illness that could compromise consent to treatment, interfere with evaluation of study medication, or present a safety concern (e.g. uncontrolled diabetes mellitus, unstable hypertension, BMI <18 or >35, seizure disorder, traumatic brain injury, Parkinson's disease, AIDS). Adequately controlled conditions (such as diabetes mellitus, hypertension, asthma, HIV infection, and hepatitis C) will not be exclusionary. Standing or or as needed medications for non-exclusionary medical conditions will be permitted.
- •Serum sodium < 136 mEq/L (i.e., below the normal range) at the time of screening.
- •Significant abnormal findings on physical examination.
- •Women who are pregnant or breastfeeding.
- •In the judgment of the investigators, the individual would be considered a poor candidate.
研究组 & 干预措施
Oxytocin
Self administration three times on the first day, then twice daily treatment with intranasal oxytocin spray for 4 days.
干预措施: Intranasal Oxytocin Spray (Drug)
Placebo
Self administration three times on the first day, then twice daily treatment with intranasal spray that does not contain oxytocin for 4 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Area Under the Curve (AUC) in COWS Total Score on Days 1 to 5 Inclusive
时间窗: From days 1-5, the measure includes scores starting at time 0 through the maximal final time of up to 120 hours.
The Clinical Opiate Withdrawal Scale (COWS) is an 11-item, observer-rated tool for quantifying withdrawal symptoms. Each section is rated from 0 (no symptom) to 4 or 5 (most severe symptom). Total score is classified into a 4 point rating scale (mild 5-12, moderate 13-24, moderately severe 25-36 and severe more than 36 points). Lower scores are more favorable.
次要结局
- AUC in Subjective Opiate Withdrawal Scale (SOWS) Total Score on Days 1 to 5 Inclusive(5 days)
- AUC in Visual Analog Scale (VAS) Score for Craving on Days 1 to 5 Inclusive(Days 1-5, the AUC includes data starting from time 0 hours up to 120 hours post-dose.)
- Speilberger State and Trait Anxiety Inventory(Daily up to 5 days)