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

February 20, 2018 updated by: Barbara MacIntyre MSN,RN, Mclean Hospital

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Withdrawn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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who experience improvement in mood
Time Frame: 6 weeks
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
Time Frame: 6 weeks
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
Time Frame: 6 weeks
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
Time Frame: 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
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mclean Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • 2013P001595

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Opioid-use Disorder

Clinical Trials on Han's Acupoint Nerve Stimulator

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kosovo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe