Acupuncture and the Relaxation Response for Substance Abuse

December 12, 2014 updated by: Bei-Hung Chang, VA Boston Healthcare System

Acupuncture and the Relaxation Response for Homeless Veterans With Substance Abuse

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Bedford, Massachusetts, United States, 01730
        • Bedford VAMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acup
Acupuncture
Procedure: Acupuncture
Experimental: RR
Relaxation Response
Behavioral: Relaxation Response
No Intervention: UC
Usual Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in self-reported substance craving rating from baseline to 10 week
Time Frame: baseline and 10 week follow up
baseline and 10 week follow up

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in anxiety level from baseline to 10 week
Time Frame: baseline and 10 week follow up
baseline and 10 week follow up
Changes in quality of life from baseline to 10 week
Time Frame: baseline and 10 week follow up
baseline and 10 week follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Boston Healthcare System

Collaborators

Samueli Institute for Information Biology

Investigators

  • Principal Investigator: Bei-Hung Chang, Sc.D., VA Boston Health Care system

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

September 11, 2006

First Submitted That Met QC Criteria

September 11, 2006

First Posted (Estimate)

September 12, 2006

Study Record Updates

Last Update Posted (Estimate)

December 15, 2014

Last Update Submitted That Met QC Criteria

December 12, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1 EA-0000041

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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