Acupuncture and the Relaxation Response for Substance Abuse

This study has been completed.
Sponsor:
Collaborator:
Samueli Institute for Information Biology
Information provided by (Responsible Party):
Bei-Hung Chang, VA Boston Healthcare System
ClinicalTrials.gov Identifier:
NCT00375102
First received: September 11, 2006
Last updated: December 12, 2014
Last verified: December 2014
  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 2
Phase 3

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

Resource links provided by NLM:


Further study details as provided by VA Boston Healthcare System:

Primary Outcome Measures:
  • Changes in self-reported substance craving rating from baseline to 10 week [ Time Frame: baseline and 10 week follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in anxiety level from baseline to 10 week [ Time Frame: baseline and 10 week follow up ] [ Designated as safety issue: No ]
  • Changes in quality of life from baseline to 10 week [ Time Frame: baseline and 10 week follow up ] [ Designated as safety issue: No ]

Enrollment: 67
Study Start Date: November 2006
Study Completion Date: November 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acup
Acupuncture
Procedure: Acupuncture
Experimental: RR
Relaxation Response
Behavioral: Relaxation Response
No Intervention: UC
Usual Care

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00375102

Locations
United States, Massachusetts
Bedford VAMC
Bedford, Massachusetts, United States, 01730
Sponsors and Collaborators
VA Boston Healthcare System
Samueli Institute for Information Biology
Investigators
Principal Investigator: Bei-Hung Chang, Sc.D. VA Boston Health Care System
  More Information

Publications:
Responsible Party: Bei-Hung Chang, Health Research Scientist, VA Boston Healthcare System
ClinicalTrials.gov Identifier: NCT00375102     History of Changes
Other Study ID Numbers: 1 EA-0000041
Study First Received: September 11, 2006
Last Updated: December 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by VA Boston Healthcare System:
acupuncture
relaxation response
homeless
veterans
randomized trials

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 27, 2015