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Acupuncture and the Relaxation Response for Substance Abuse

Primary Purpose

Substance Abuse

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
Relaxation Response
Sponsored by
VA Boston Healthcare System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Abuse focused on measuring acupuncture, relaxation response, homeless, veterans, randomized trials

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Have a substance abuse or dependence problem of any type of substance
  2. Stay in the domiciliary for at least 10 weeks after the study entry to complete the study.

Exclusion Criteria:

  1. Schizophrenia or psychotic diagnoses
  2. Bleeding disorders (hemophilia or thrombocytopenia)
  3. An allergy to metals (needles).

Sites / Locations

  • Bedford VAMC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Acup

RR

UC

Arm Description

Acupuncture

Relaxation Response

Usual Care

Outcomes

Primary Outcome Measures

Changes in self-reported substance craving rating from baseline to 10 week

Secondary Outcome Measures

Changes in anxiety level from baseline to 10 week
Changes in quality of life from baseline to 10 week

Full Information

First Posted
September 11, 2006
Last Updated
December 12, 2014
Sponsor
VA Boston Healthcare System
Collaborators
Samueli Institute for Information Biology
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1. Study Identification

Unique Protocol Identification Number
NCT00375102
Brief Title
Acupuncture and the Relaxation Response for Substance Abuse
Official Title
Acupuncture and the Relaxation Response for Homeless Veterans With Substance Abuse
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA Boston Healthcare System
Collaborators
Samueli Institute for Information Biology

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This one-year pilot study has two specific aims: 1. to determine the feasibility of conducting a randomized controlled trial of acupuncture and the relaxation response for substance abuse among homeless veterans who are in a domiciliary care program, and 2. to collect and analyze pilot data to estimate the effect size for planning a future larger study to fully test the hypothesis of the effectiveness of acupuncture and the RR in reducing cravings for substances (alcohol and drugs), and the corollary effects on quality of life.
Detailed Description
Substance abuse is one of the most important risk factors for homelessness. A high proportion of the US homeless population are veterans, in large part due to the high prevalence of substance abuse among veterans. Thus, effective substance abuse treatment in veterans is essential to preventing homelessness, as well as reintegrating those already homeless. Traditional substance abuse therapies have shown inconsistent effectiveness, suggesting a need for alternative therapies. Acupuncture and the relaxation response (RR) are two commonly used complementary and alternative medicine modalities that have shown benefit in some studies. However, they have not been studied in homeless veterans who have completed detoxification treatment and are in early remission. Acupuncture and the RR share common features, yet have distinct differences. Acupuncture has to be administered by acupuncturists, while RR elicitation is a self-care strategy that can be learned and practiced anytime and anywhere. We propose a pilot study to determine the feasibility of conducting a three-arm randomized controlled trial on veterans in the Bedford Domiciliary Care for Homeless Veterans program and to collect pilot data for planning future larger studies to test the effectiveness of acupuncture and the RR in reducing substance craving and improving anxiety and quality of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse
Keywords
acupuncture, relaxation response, homeless, veterans, randomized trials

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acup
Arm Type
Experimental
Arm Description
Acupuncture
Arm Title
RR
Arm Type
Experimental
Arm Description
Relaxation Response
Arm Title
UC
Arm Type
No Intervention
Arm Description
Usual Care
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Intervention Type
Behavioral
Intervention Name(s)
Relaxation Response
Primary Outcome Measure Information:
Title
Changes in self-reported substance craving rating from baseline to 10 week
Time Frame
baseline and 10 week follow up
Secondary Outcome Measure Information:
Title
Changes in anxiety level from baseline to 10 week
Time Frame
baseline and 10 week follow up
Title
Changes in quality of life from baseline to 10 week
Time Frame
baseline and 10 week follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have a substance abuse or dependence problem of any type of substance Stay in the domiciliary for at least 10 weeks after the study entry to complete the study. Exclusion Criteria: Schizophrenia or psychotic diagnoses Bleeding disorders (hemophilia or thrombocytopenia) An allergy to metals (needles).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bei-Hung Chang, Sc.D.
Organizational Affiliation
VA Boston Health Care System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bedford VAMC
City
Bedford
State/Province
Massachusetts
ZIP/Postal Code
01730
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25187049
Citation
Chang BH, Sommers E. Acupuncture and relaxation response for craving and anxiety reduction among military veterans in recovery from substance use disorder. Am J Addict. 2014 Mar-Apr;23(2):129-36. doi: 10.1111/j.1521-0391.2013.12079.x. Epub 2013 Aug 30.
Results Reference
result
Citation
Chang BH, Elizabeth Sommers, Lawrence Herz, Acupuncture and relaxation response for substance use disorder recovery, Journal of Substance Use, 2010, 15(6): 390-401.
Results Reference
result

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Acupuncture and the Relaxation Response for Substance Abuse

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