A Crossover Study Using Transdermal Electroacupuncture as Adjunctive Treatment to Reduce Opiate Cravings in Post-Detox Outpatients Receiving Buprenorphine-Naloxone
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Number of participants who attend all 12 Transdermal Electroacupuncture (TEAS) sessions
研究概览
简要总结
Pilot study of 12 outpatients in early recovery from illicit drug use,post-detox and on buprenorphine-naloxone maintenance will be offered 12 TEAS adjunct treatments over 6 weeks(X2/week) to ascertain if they experience any improvement in mood,sleep,overall quality of life and decrease drug cravings ultimately while facing everyday life stressors.
详细描述
- this crossover study will involve participants who will be randomized into two treatment groups,A&B. TEAS treatments will be given for 30 minutes,X2/week,for 6 weeks(12total sessions). Group A will receive 2 weeks(4 sessions) of active treatment followed by 4 weeks of sham treatment(8 sessions). Group B will receive 2 weeks(4 sessions) of sham treatment,2 weeks (4 sessions)of real treatment,and finally 2 weeks (4 sessions) of sham treatment.
- parameters to be measured include vital signs and questionnaires weeks 1,3,5,6 to assess self-reported past 14-day substance use,alcohol and drug craving,withdrawal symptoms,sleep,mood,pain and overall quality of life.
- goals include better lives for post-detox opiate addicts as they incorporate this treatment into their lives,saving themselves and loved ones more horror,and their communities resources.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-59 years old
- •early recovery(0-3months of abstinence
- •not currently detoxing
- •maintained on buprenorphine-naloxone under the care of qualified MD
- •proficient in the English language
排除标准
- •having acute,psychiatric symptoms which would pose safety concerns,or an adherence to treatment barrier(active suicidality/psychosis/mania)
- •severe cognitive disorders*not competent to give informed consent
- •active cardiac disease or EKG abnormalities or with cardiac pacemaker
- •currently detoxing from alcohol or illicit drugs
- •inability or non-intention to attend all treatment sessions*history of seizures*pregnancy or breast feeding.
研究组 & 干预措施
Transdermal Electroacupuncture - Arm A
week 1-2 real treatment, week 3-6 sham treatment with Han's Acupoint Nerve Stimulator while receiving concurrent buprenorphine-naloxone as prescribed
干预措施: Han's Acupoint Nerve Stimulator (Device)
Transdermal Electroacupuncture - Arm B
week 1-2 real treatment, week 3-6 sham treatment with Han's Acupoint Nerve Stimulator treatment while receiving concurrent buprenorphine-naloxone as prescribed
干预措施: Han's Acupoint Nerve Stimulator (Device)
结局指标
主要结局
Number of participants who attend all 12 Transdermal Electroacupuncture (TEAS) sessions
时间窗: 6 weeks
次要结局
- Number of participants who experience improvement in sleep(6 weeks)
- Number of participants who report fewer cravings for drugs and alcohol(6 weeks)
- Number of participants who experience improvement in mood(6 weeks)
- Number of participants who experience improvement in Quality-of-Life(6 weeks)
研究者
Barbara MacIntyre MSN,RN
Barbara MacIntyre MSN,RN
Mclean Hospital