Oxytocin Treatment of Alcohol Dependence: A Randomized, Placebo-Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 13
- 主要终点
- Change in Clinical Institute Withdrawal Assessment for Alcohol (CIWA) Score
研究概览
简要总结
This study will test in individuals who have alcohol dependence (alcohol addiction) the hypotheses 1) that intranasal oxytocin treatment will decrease withdrawal symptoms during medical detoxification and 2) that intranasal oxytocin treatment for 12 weeks in the outpatient setting will decrease drinking.
详细描述
Study Design This is a randomized, double blind, placebo-controlled early phase II clinical trial.
Recruitment: The study has 2 phases. The first is testing intranasal treatments (oxytocin [OT], placebo) on alcohol withdrawal (the inpatient phase) and the second is testing intranasal treatments on alcohol drinking, craving and anxiety over 12 weeks in the outpatient setting (the outpatient phase). Subjects for the inpatient phase will only be recruited from patients admitted to Freedom House (FRH, mental health center in Chapel Hill, NC) for medical detoxification from alcohol within the last 36 hours. Subjects for the outpatient phase of the study will be inpatients at FRH or the University of North Carolina (UNC) Hospitals who are near the end of their inpatient stay (medical detoxification has been or is nearly completed). Subjects in the inpatient phase of the study at FRH may continue into the outpatient phase after discharge. Subjects for the outpatient phase will also be heavy drinkers from the community who are screened during an initial outpatient clinic visit.
Patients newly admitted to FRH to treat alcohol withdrawal will undergo a brief screening that includes: 1) a recent and past alcohol use interview (Time Line Follow Back, TLFB) and history of alcohol withdrawal interview; 2) a brief psychiatric interview; 3 ) a score on the 10-item CIWA scale of alcohol withdrawal symptoms; 4) a review of potential medical exclusion criteria including a history of seizures or delirium tremens; 5) a spot urine pregnancy test on all prospective female subjects.
Recruitment into the outpatient phase (treatment of outpatient drinking): Patients who undergo medical detoxification from alcohol will be recruited from FRH or from UNC Hospitals toward the end of their admission for participation in a trial to test the efficacy of intranasal OT vs. placebo treatment on alcohol drinking, alcohol craving and anxiety during a 12-week outpatient treatment period. They will be screened to see if they meet study criteria. These individuals will read and sign the Breath Alcohol Policy that states that if their Breathalyzer reading at the beginning of an outpatient clinic visit is >.08 they will not be assessed at that visit and will not drive themselves home but rather will accept a ride from a family member, friend or a cab driver.
Other individuals will be recruited from the community for participation in the outpatient phase of the study who have responded to a radio ad, a UNC listserve ad, a flyer, have been referred by local clinicians or have otherwise become aware of the study. These prospective subjects will undergo a telephone screening interview. If they appear to meet criteria over the phone, they will be further screened during an outpatient clinic visit. They must sign the Breath Alcohol Policy.
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)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria for the inpatient phase (alcohol withdrawal treatment) of the study
- •Meeting criteria for DSM-IV (Diagnostic and Statistical Manual-IV-TR) alcohol dependence.
- •At least one prior episode of DSM-IV alcohol withdrawal as assessed by SCID Alcohol Dependence Module or scoring > 6 on the CIWA scale since admission to the inpatient unit, or having any of the following elevated vital signs since admission: pulse > 110; diastolic blood pressure > 100; systolic blood pressure >
- •At least 12 heavy drinking days in the 28 days prior to enrollment in the study. A heavy drinking day is defined as >5 standard drinks for men or >4 standard drinks for women.
- •Women who are able to conceive children must be on an effective form of birth control such as oral contraceptives, intrauterine devices or the use of condoms with spermicide.
- •Competency to give valid informed consent as indicated by a) a breathalyzer reading at the time the consent form is signed showing an estimated blood alcohol level (BAL) <.08 gm/dL (the consent process is repeated when the BAL level has dropped to 0.00 gm/dL) and b) ability to understand the written informed consent form demonstrated by correctly answering questions about the contents of the form after reading the consent form without help (this will also determine whether prospective subjects can read and understand the study questionnaires).
- •Ability to get to appointments either through personal or public transportation.
- •Inclusion Criteria for the outpatient phase of the study (treatment of heavy drinking) for prospective subjects screened toward the end of their FRH or UNC inpatient stay The same criteria as those listed above for the inpatient phase of the study apply except for the criteria marked with an asterisk.
- •Inclusion Criteria for the outpatient phase of the study for prospective subjects recruited from the community and screened during an initial outpatient clinic visit The same criteria as those listed above for the inpatient alcohol withdrawal treatment phase of the study apply except for having a previous history of alcohol withdrawal (inclusion criterion #2)
排除标准
- •Exclusion Criteria for the inpatient alcohol withdrawal treatment phase of the study
- •History of alcohol withdrawal-related seizures, delirium tremens or hallucinations.
- •Clinically significant medical disease that might interfere with the evaluation of the study medication or present a safety concern (e.g., renal insufficiency, cirrhosis, unstable hypertension, unstable diabetes mellitus, seizure disorder). Clinically significant psychiatric illnesses including any psychotic disorder, bipolar disorder, eating disorder, severe depression, or suicidal ideation.
- •Other substance dependence disorder with the exceptions of nicotine or caffeine. Substance abuse disorders are not exclusionary.
- •Chronic or subchronic ( >3 days in the week prior to admission or outpatient enrollment) treatment with/consumption of benzodiazepines, barbiturates, anticonvulsants or stimulants.
- •Receipt of >6 mg of lorazepam or any dose of a long half-life benzodiazepine between admission for medical detoxification and beginning participation in the study (i.e., receiving the first intranasal dose of test treatment).
- •AST or ALT (liver function tests) > 5 times ULN (upper level of normal), bilirubin (liver function test) > 1.5 X ULN, sodium < 132 or > 150 mMol/L, potassium < 3.2 or > 5.3 mMol/L.
- •Women who are pregnant or breastfeeding.
- •Intent to participate in an additional alcohol treatment program other than Alcoholics Anonymous
- •Court-mandated participation in alcohol treatment or pending incarceration.
- •Exclusion Criteria for the outpatient phase of the study (treatment of heavy drinking) for prospective subjects screened toward the end of their FRH or UNC inpatient stay The same criteria as those listed above for the inpatient phase of the study apply except for the criteria marked with an asterisk.
研究组 & 干预措施
Intranasal oxytocin spray (Syntocinon Spray)
TID inpatient; BID outpatient for 12 wks
干预措施: intranasal oxytocin spray (Drug)
Intranasal Placebo Spray
TID inpatient; BID outpatient for 12 wks
干预措施: intranasal oxytocin spray (Drug)
Intranasal Placebo Spray
TID inpatient; BID outpatient for 12 wks
干预措施: Intranasal Placebo Spray (Drug)
结局指标
主要结局
Change in Clinical Institute Withdrawal Assessment for Alcohol (CIWA) Score
时间窗: Change in scores from before initiation of intranasal test treatment and the first 48 hours after initiation of intranasal test treatments
The Clinical Institute Withdrawal Assessment for Alcohol (CIWA) measure is a ten item measure of alcohol withdrawal symptoms. The CIWA total score is the summation of 10 questions, with a range from 0 (little to no withdrawal) to 67 (worse alcohol withdrawal).
次要结局
- Total mg of Lorazepam for Detoxification(48 hours after initiation of intranasal test doses)
- Change in Percentage Heavy Drinking Days(90 days prior to admission and 4 weeks in the outpatient setting)
研究者
Cort Pedersen, MD
Principal Investigator
University of North Carolina, Chapel Hill