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

N/AWithdrawnNCT02033746

Mclean Hospital

Overview

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.

* 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Conditions

Opioid-use Disorder

Interventions

Han's Acupoint Nerve StimulatorDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 59 Years

Medical Language ↔ Plain English

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.

Locations (1)

McLean Hospital

Belmont, Massachusetts, United States

Outcomes

Primary Outcomes

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

Time frame: 6 weeks

Secondary Outcomes

Number of participants who experience improvement in mood

Mood measured by self-report on the Quick Inventory of Depressive Symptomatology (QIDS-SR-16) questionnaire.

Time frame: 6 weeks

Number of participants who experience improvement in sleep

Sleep patterns measure by self report through the Pittsburgh Sleep Quality Index (PSQI) questionnaire

Time frame: 6 weeks

Number of participants who experience improvement in Quality-of-Life

Quality-of-Life measured by self-report through Short Form (SF)-36 questionnaire

Time frame: 6 weeks

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

Time frame: 6 weeks

Data from ClinicalTrials.gov

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