Acupuncture and the Relaxation Response for Substance Abuse

Substance Abuse Clinical Trial

Official title:

Acupuncture and the Relaxation Response for Homeless Veterans With Substance Abuse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00375102
• Other study ID #: 1 EA-0000041
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 11, 2006
• Last updated: December 12, 2014
• Start date: November 2006
• Est. completion date: November 2007

Study information

• Verified date: December 2014
• Source: VA Boston Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: November 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Substance Abuse
• Substance-Related Disorders

Intervention

Procedure:
• Acupuncture

Behavioral:
• Relaxation Response

Locations

Country	Name	City	State
United States	Bedford VAMC	Bedford	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
VA Boston Healthcare System	Samueli Institute for Information Biology

Country where clinical trial is conducted

United States, 

References & Publications (2)

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in self-reported substance craving rating from baseline to 10 week		baseline and 10 week follow up	No
Secondary	Changes in anxiety level from baseline to 10 week		baseline and 10 week follow up	No
Secondary	Changes in quality of life from baseline to 10 week		baseline and 10 week follow up	No