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Acupuncture and the Relaxation Response for Substance Abuse

NCT ID: NCT00375102

Last Updated: 2014-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2007-11-30

Brief Summary

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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

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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.

Conditions

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Substance Abuse

Keywords

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acupuncture relaxation response homeless veterans randomized trials

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Acup

Acupuncture

Group Type EXPERIMENTAL

Acupuncture

Intervention Type PROCEDURE

RR

Relaxation Response

Group Type EXPERIMENTAL

Relaxation Response

Intervention Type BEHAVIORAL

UC

Usual Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Acupuncture

Intervention Type PROCEDURE

Relaxation Response

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samueli Institute for Information Biology

OTHER

Sponsor Role collaborator

VA Boston Healthcare System

FED

Sponsor Role lead

Responsible Party

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Bei-Hung Chang

Health Research Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bei-Hung Chang, Sc.D.

Role: PRINCIPAL_INVESTIGATOR

VA Boston Health Care System

Locations

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Bedford VAMC

Bedford, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 25187049 (View on PubMed)

Chang BH, Elizabeth Sommers, Lawrence Herz, Acupuncture and relaxation response for substance use disorder recovery, Journal of Substance Use, 2010, 15(6): 390-401.

Reference Type RESULT

Other Identifiers

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1 EA-0000041

Identifier Type: -

Identifier Source: org_study_id