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Completed

NCT Number: NCT00375102

Acupuncture and the Relaxation Response for 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Bedford VAMC

Bedford, Massachusetts, 01730, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Acupuncture

Procedure

Relaxation Response

Behavioral

Primary outcomes

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

    Time frame: baseline and 10 week follow up

Secondary outcomes

  1. Changes in anxiety level from baseline to 10 week

    Time frame: baseline and 10 week follow up

  2. Changes in quality of life from baseline to 10 week

    Time frame: baseline and 10 week follow up

Sponsors and collaborators

Lead sponsor

VA Boston Healthcare System

Fed

Collaborators

  • Samueli Institute for Information Biology

Registry information

Official study title

Acupuncture and the Relaxation Response for Homeless Veterans With Substance Abuse

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Sep 12, 2006
Registry last updated
Dec 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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