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
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Aug 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 3, 2014
CompletedFirst Posted
Study publicly available on registry
January 13, 2014
CompletedStudy Start
First participant enrolled
August 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedFebruary 22, 2018
February 1, 2018
2 years
January 3, 2014
February 20, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants who attend all 12 Transdermal Electroacupuncture (TEAS) sessions
6 weeks
Secondary Outcomes (4)
Number of participants who experience improvement in mood
6 weeks
Number of participants who experience improvement in sleep
6 weeks
Number of participants who experience improvement in Quality-of-Life
6 weeks
Number of participants who report fewer cravings for drugs and alcohol
6 weeks
Study Arms (2)
Transdermal Electroacupuncture - Arm A
EXPERIMENTALweek 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
EXPERIMENTALweek 1-2 real treatment, week 3-6 sham treatment with Han's Acupoint Nerve Stimulator treatment while receiving concurrent buprenorphine-naloxone as prescribed
Interventions
frequency delivery(3 seconds of 2 Hz followed by 3 seconds of 100 Hz(dense disperse method).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mclean Hospitallead
Study Sites (1)
McLean Hospital
Belmont, Massachusetts, 02478, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Barbara A MacIntyre, MSN,RN
Mclean Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Barbara MacIntyre MSN,RN
Study Record Dates
First Submitted
January 3, 2014
First Posted
January 13, 2014
Study Start
August 1, 2015
Primary Completion
August 1, 2017
Study Completion
December 1, 2017
Last Updated
February 22, 2018
Record last verified: 2018-02