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| Sponsor: | VA Boston Healthcare System |
|---|---|
| Collaborator: |
Samueli Institute for Information Biology |
| Information provided by: | VA Boston Healthcare System |
| ClinicalTrials.gov Identifier: | NCT00375102 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Substance Abuse |
Procedure: Acupuncture Behavioral: Relaxation Response |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Acupuncture and the Relaxation Response for Homeless Veterans With Substance Abuse |
| Study Start Date: | November 2006 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Massachusetts | |
| Bedford VAMC | |
| Bedford, Massachusetts, United States, 01730 | |
| Principal Investigator: | Bei-Hung Chang, Sc.D. | VA Boston Health Care System |
More Information
| ClinicalTrials.gov Identifier: | NCT00375102 History of Changes |
| Other Study ID Numbers: | 1 EA-0000041 |
| Study First Received: | September 11, 2006 |
| Last Updated: | September 14, 2007 |
| Health Authority: | United States: Institutional Review Board |
|
acupuncture relaxation response homeless veterans randomized trials |
|
Substance-Related Disorders Mental Disorders |