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Trial record 83 of 186 for:    BUPRENORPHINE AND NALOXONE

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

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ClinicalTrials.gov Identifier: NCT02033746
Recruitment Status : Withdrawn
First Posted : January 13, 2014
Last Update Posted : February 21, 2018
Sponsor:
Information provided by (Responsible Party):
Barbara MacIntyre MSN,RN, Mclean Hospital

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.

Condition or disease Intervention/treatment Phase
Opioid-use Disorder Device: Han's Acupoint Nerve Stimulator Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Crossover Study Using Transdermal Electroacupuncture as Adjunctive Treatment to Reduce Opiate Cravings in Post-Detox Outpatients Receiving Buprenorphine-Naloxone
Actual Study Start Date : August 2015
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : December 2017

Arm Intervention/treatment
Experimental: 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
Device: Han's Acupoint Nerve Stimulator
frequency delivery(3 seconds of 2 Hz followed by 3 seconds of 100 Hz(dense disperse method).

Experimental: 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
Device: Han's Acupoint Nerve Stimulator
frequency delivery(3 seconds of 2 Hz followed by 3 seconds of 100 Hz(dense disperse method).




Primary Outcome Measures :
  1. Number of participants who attend all 12 Transdermal Electroacupuncture (TEAS) sessions [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Number of participants who experience improvement in mood [ Time Frame: 6 weeks ]
    Mood measured by self-report on the Quick Inventory of Depressive Symptomatology (QIDS-SR-16) questionnaire.

  2. Number of participants who experience improvement in sleep [ Time Frame: 6 weeks ]
    Sleep patterns measure by self report through the Pittsburgh Sleep Quality Index (PSQI) questionnaire

  3. Number of participants who experience improvement in Quality-of-Life [ Time Frame: 6 weeks ]
    Quality-of-Life measured by self-report through Short Form (SF)-36 questionnaire

  4. Number of participants who report fewer cravings for drugs and alcohol [ Time Frame: 6 weeks ]
    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



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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02033746


Locations
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United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478
Sponsors and Collaborators
Mclean Hospital
Investigators
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Principal Investigator: Barbara A MacIntyre, MSN,RN Mclean Hospital

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Responsible Party: Barbara MacIntyre MSN,RN, Mclean Hospital
ClinicalTrials.gov Identifier: NCT02033746     History of Changes
Other Study ID Numbers: 2013P001595
First Posted: January 13, 2014    Key Record Dates
Last Update Posted: February 21, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
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Buprenorphine
Buprenorphine, Naloxone Drug Combination
Naloxone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists