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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

September 11, 2006
December 12, 2014
November 2006
September 2007   (final data collection date for primary outcome measure)
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 ]
self-reported substance craving rating
Complete list of historical versions of study NCT00375102 on ClinicalTrials.gov Archive Site
  • 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 ]
anxiety, physical, mental and spiritual quality of life measures, and irregular discharges.
Not Provided
Not Provided
 
Acupuncture and the Relaxation Response for Substance Abuse
Acupuncture and the Relaxation Response for Homeless Veterans With 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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Substance Abuse
  • Procedure: Acupuncture
  • Behavioral: Relaxation Response
  • Experimental: Acup
    Acupuncture
    Intervention: Procedure: Acupuncture
  • Experimental: RR
    Relaxation Response
    Intervention: Behavioral: Relaxation Response
  • No Intervention: UC
    Usual Care
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
67
November 2007
September 2007   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00375102
1 EA-0000041
No
Bei-Hung Chang, VA Boston Healthcare System
VA Boston Healthcare System
Samueli Institute for Information Biology
Principal Investigator: Bei-Hung Chang, Sc.D. VA Boston Health Care System
VA Boston Healthcare System
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP