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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Opioid-use Disorder
• Intervention / Treatment: Device: Han's Acupoint Nerve Stimulator

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Belmont, Massachusetts, United States, 02478
      • McLean Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 59 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: Han's Acupoint Nerve Stimulator; frequency delivery(3 seconds of 2 Hz followed by 3 seconds of 100 Hz(dense disperse method).
Experimental: 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	Device: Han's Acupoint Nerve Stimulator; frequency delivery(3 seconds of 2 Hz followed by 3 seconds of 100 Hz(dense disperse method).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Mclean Hospital
• Investigators: Principal Investigator: Barbara A MacIntyre, MSN,RN, McLean Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Anticipated): August 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: January 3, 2014
• First Submitted That Met QC Criteria: January 9, 2014
• First Posted (Estimate): January 13, 2014

Study Record Updates

• Last Update Posted (Actual): February 22, 2018
• Last Update Submitted That Met QC Criteria: February 20, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders
• Other Study ID Numbers: 2013P001595