Acupuncture and the Relaxation Response for Substance Abuse
1 other identifier
interventional
67
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2006
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 11, 2006
CompletedFirst Posted
Study publicly available on registry
September 12, 2006
CompletedStudy Start
First participant enrolled
November 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedDecember 15, 2014
December 1, 2014
10 months
September 11, 2006
December 12, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in self-reported substance craving rating from baseline to 10 week
baseline and 10 week follow up
Secondary Outcomes (2)
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
Study Arms (3)
Acup
EXPERIMENTALAcupuncture
RR
EXPERIMENTALRelaxation Response
UC
NO INTERVENTIONUsual Care
Interventions
Eligibility Criteria
You may qualify if:
- Have a substance abuse or dependence problem of any type of substance
- Stay in the domiciliary for at least 10 weeks after the study entry to complete the study.
You may not qualify if:
- Schizophrenia or psychotic diagnoses
- Bleeding disorders (hemophilia or thrombocytopenia)
- An allergy to metals (needles).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bedford VAMC
Bedford, Massachusetts, 01730, United States
Related Publications (2)
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.
PMID: 25187049RESULTChang BH, Elizabeth Sommers, Lawrence Herz, Acupuncture and relaxation response for substance use disorder recovery, Journal of Substance Use, 2010, 15(6): 390-401.
RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bei-Hung Chang, Sc.D.
VA Boston Health Care System
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Health Research Scientist
Study Record Dates
First Submitted
September 11, 2006
First Posted
September 12, 2006
Study Start
November 1, 2006
Primary Completion
September 1, 2007
Study Completion
November 1, 2007
Last Updated
December 15, 2014
Record last verified: 2014-12