Opiate Craving Reduction Study Using Post-detox Patients on Suboxone and Use of TEAS as Adjunctive Treatment

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Crossover Study Using Transdermal Electroacupuncture as Adjunctive Treatment to Reduce Opiate Cravings in Post-Detox Outpatients Receiving Buprenorphine-Naloxone

Conditions
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Opioid-use Disorder

Intervention / Treatment
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* Device: Han's Acupoint Nerve Stimulator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transdermal Electroacupuncture - Arm A<br>week 1-2 real treatment, week 3-6 sham treatment with Han's Acupoint Nerve Stimulator while receiving concurrent buprenorphine-naloxone as prescribed | Device: Han's Acupoint Nerve Stimulator<br>* frequency delivery(3 seconds of 2 Hz followed by 3 seconds of 100 Hz(dense disperse method).<br>|
| Experimental: Transdermal Electroacupuncture - Arm B<br>week 1-2 real treatment, week 3-6 sham treatment with Han's Acupoint Nerve Stimulator treatment while receiving concurrent buprenorphine-naloxone as prescribed | Device: Han's Acupoint Nerve Stimulator<br>* frequency delivery(3 seconds of 2 Hz followed by 3 seconds of 100 Hz(dense disperse method).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who attend all 12 Transdermal Electroacupuncture (TEAS) sessions |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who experience improvement in mood | Mood measured by self-report on the Quick Inventory of Depressive Symptomatology (QIDS-SR-16) questionnaire. | 6 weeks | 
| Number of participants who experience improvement in sleep | Sleep patterns measure by self report through the Pittsburgh Sleep Quality Index (PSQI) questionnaire | 6 weeks | 
| Number of participants who experience improvement in Quality-of-Life | Quality-of-Life measured by self-report through Short Form (SF)-36 questionnaire | 6 weeks | 
| Number of participants who report fewer cravings for drugs and alcohol | 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 | 6 weeks |