Acupuncture and the Relaxation Response for Substance Abuse

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2007 by VA Boston Healthcare System.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Samueli Institute for Information Biology
Information provided by:
VA Boston Healthcare System
ClinicalTrials.gov Identifier:
NCT00375102
First received: September 11, 2006
Last updated: September 14, 2007
Last verified: September 2007

September 11, 2006
September 14, 2007
November 2006
Not Provided
self-reported substance craving rating
Same as current
Complete list of historical versions of study NCT00375102 on ClinicalTrials.gov Archive Site
anxiety, physical, mental and spiritual quality of life measures, and irregular discharges.
Same as current
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
Not Provided
Not Provided
Not Provided

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
Not Provided
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00375102
1 EA-0000041
Not Provided
Not Provided
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
September 2007

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