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

Mass General Brigham

Status: Withdrawn

Conditions: Opioid-use Disorder

Treatments: Device: Han's Acupoint Nerve Stimulator

Study type: Interventional

Funder types: Other

Identifiers

NCT02033746

2013P001595

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 59 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Transdermal Electroacupuncture - Arm A

Experimental group

Description:

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

Treatment:

Device: Han's Acupoint Nerve Stimulator

Transdermal Electroacupuncture - Arm B

Experimental group

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

Treatment:

Device: Han's Acupoint Nerve Stimulator