Acupuncture and the Relaxation Response for Substance Abuse

Phase 2

Completed

• Conditions: Substance Abuse
• Interventions: Procedure: Acupuncture; Behavioral: Relaxation Response

• Registration Number: NCT00375102
• Lead Sponsor: VA Boston Healthcare System

Brief 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.

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 Timeline

• Study First Submitted: 2006-09-11
• Study First Submitted QC: 2006-09-11
• Study First Posted: 2006-09-12
• Study Start: 2006-11
• Primary Completion: 2007-09
• Study Completion: 2007-11
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-12
• Last Update Posted: 2014-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acup	Acupuncture	Acupuncture
RR	Relaxation Response	Relaxation Response

Primary Outcome Measures

Name	Time	Method
Changes in self-reported substance craving rating from baseline to 10 week	baseline and 10 week follow up

Secondary Outcome Measures

Name	Time	Method
Changes in anxiety level from baseline to 10 week	baseline and 10 week follow up
Changes in quality of life from baseline to 10 week	baseline and 10 week follow up

Trial Locations

Locations (1)

Bedford VAMC; 🇺🇸 Bedford, Massachusetts, United States