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

NCT ID: NCT02033746

Last Updated: 2018-02-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2017-12-31

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.

Conditions

Opioid-use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Han's Acupoint Nerve Stimulator

Intervention Type: DEVICE

frequency delivery(3 seconds of 2 Hz followed by 3 seconds of 100 Hz(dense disperse method).

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

Group Type: EXPERIMENTAL

Han's Acupoint Nerve Stimulator

Intervention Type: DEVICE

frequency delivery(3 seconds of 2 Hz followed by 3 seconds of 100 Hz(dense disperse method).

Interventions

Han's Acupoint Nerve Stimulator

frequency delivery(3 seconds of 2 Hz followed by 3 seconds of 100 Hz(dense disperse method).

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mclean Hospital

OTHER

Sponsor Role: lead

Responsible Party

Barbara MacIntyre MSN,RN

Barbara MacIntyre MSN,RN

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Barbara A MacIntyre, MSN,RN

Role: PRINCIPAL_INVESTIGATOR

Mclean Hospital

Locations

McLean Hospital

Belmont, Massachusetts, United States

Countries

United States

Other Identifiers

2013P001595

Identifier Type: -

Identifier Source: org_study_id