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

Primary Purpose

Opioid-use Disorder

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Han's Acupoint Nerve Stimulator
Sponsored by
Mclean Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid-use Disorder

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • McLean Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Transdermal Electroacupuncture - Arm A

Transdermal Electroacupuncture - Arm B

Arm Description

week 1-2 real treatment, week 3-6 sham treatment with Han's Acupoint Nerve Stimulator while receiving concurrent buprenorphine-naloxone as prescribed

week 1-2 real treatment, week 3-6 sham treatment with Han's Acupoint Nerve Stimulator treatment while receiving concurrent buprenorphine-naloxone as prescribed

Outcomes

Primary Outcome Measures

Number of participants who attend all 12 Transdermal Electroacupuncture (TEAS) sessions

Secondary Outcome Measures

Number of participants who experience improvement in mood
Mood measured by self-report on the Quick Inventory of Depressive Symptomatology (QIDS-SR-16) questionnaire.
Number of participants who experience improvement in sleep
Sleep patterns measure by self report through the Pittsburgh Sleep Quality Index (PSQI) questionnaire
Number of participants who experience improvement in Quality-of-Life
Quality-of-Life measured by self-report through Short Form (SF)-36 questionnaire
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

Full Information

First Posted
January 3, 2014
Last Updated
February 20, 2018
Sponsor
Mclean Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02033746
Brief Title
Opiate Craving Reduction Study Using Post-detox Patients on Suboxone and Use of TEAS as Adjunctive Treatment
Official Title
A Crossover Study Using Transdermal Electroacupuncture as Adjunctive Treatment to Reduce Opiate Cravings in Post-Detox Outpatients Receiving Buprenorphine-Naloxone
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Withdrawn
Study Start Date
August 2015 (Actual)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mclean Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-use Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transdermal Electroacupuncture - Arm A
Arm Type
Experimental
Arm Description
week 1-2 real treatment, week 3-6 sham treatment with Han's Acupoint Nerve Stimulator while receiving concurrent buprenorphine-naloxone as prescribed
Arm Title
Transdermal Electroacupuncture - Arm B
Arm Type
Experimental
Arm Description
week 1-2 real treatment, week 3-6 sham treatment with Han's Acupoint Nerve Stimulator treatment while receiving concurrent buprenorphine-naloxone as prescribed
Intervention Type
Device
Intervention Name(s)
Han's Acupoint Nerve Stimulator
Intervention Description
frequency delivery(3 seconds of 2 Hz followed by 3 seconds of 100 Hz(dense disperse method).
Primary Outcome Measure Information:
Title
Number of participants who attend all 12 Transdermal Electroacupuncture (TEAS) sessions
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Number of participants who experience improvement in mood
Description
Mood measured by self-report on the Quick Inventory of Depressive Symptomatology (QIDS-SR-16) questionnaire.
Time Frame
6 weeks
Title
Number of participants who experience improvement in sleep
Description
Sleep patterns measure by self report through the Pittsburgh Sleep Quality Index (PSQI) questionnaire
Time Frame
6 weeks
Title
Number of participants who experience improvement in Quality-of-Life
Description
Quality-of-Life measured by self-report through Short Form (SF)-36 questionnaire
Time Frame
6 weeks
Title
Number of participants who report fewer cravings for drugs and alcohol
Description
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
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara A MacIntyre, MSN,RN
Organizational Affiliation
Mclean Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
McLean Hospital
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States

12. IPD Sharing Statement

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

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