Belmont, Massachusetts 02478


Purpose:

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 summary:

- 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.


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.


NCT ID:

NCT02033746


Primary Contact:

Principal Investigator
Barbara A MacIntyre, MSN,RN
Mclean Hospital

Barbara A MacIntyre, MSN, RN
Phone: 617-855-2771
Email: bmacintyre@partners.org


Backup Contact:

N/A


Location Contact:

Belmont, Massachusetts 02478
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 22, 2017

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