Opiate Craving Reduction Study Using Post-detox Patients on Suboxone and Use of TEAS as Adjunctive Treatment
- Conditions
- Opioid-use Disorder
- Interventions
- Device: Han's Acupoint Nerve Stimulator
- Registration Number
- NCT02033746
- Lead Sponsor
- Mclean Hospital
- Brief Summary
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.
- Detailed Description
* 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Transdermal Electroacupuncture - Arm A Han's Acupoint Nerve Stimulator week 1-2 real treatment, week 3-6 sham treatment with Han's Acupoint Nerve Stimulator while receiving concurrent buprenorphine-naloxone as prescribed Transdermal Electroacupuncture - Arm B Han's Acupoint Nerve Stimulator week 1-2 real treatment, week 3-6 sham treatment with Han's Acupoint Nerve Stimulator treatment while receiving concurrent buprenorphine-naloxone as prescribed
- Primary Outcome Measures
Name Time Method Number of participants who attend all 12 Transdermal Electroacupuncture (TEAS) sessions 6 weeks
- Secondary Outcome Measures
Name Time Method Number of participants who experience improvement in mood 6 weeks Mood measured by self-report on the Quick Inventory of Depressive Symptomatology (QIDS-SR-16) questionnaire.
Number of participants who experience improvement in sleep 6 weeks Sleep patterns measure by self report through the Pittsburgh Sleep Quality Index (PSQI) questionnaire
Number of participants who report fewer cravings for drugs and alcohol 6 weeks Cravings for drugs and alcohol measure by self-report through the Brief Addiction Monitor (BAM), the Craving Scale (CS), the Subjective Opiate Withdrawal Scale (SOWS), Substance Use Report, and a Brief Pain Inventory
Number of participants who experience improvement in Quality-of-Life 6 weeks Quality-of-Life measured by self-report through Short Form (SF)-36 questionnaire
Trial Locations
- Locations (1)
McLean Hospital
🇺🇸Belmont, Massachusetts, United States