Acupuncture and the Relaxation Response for Substance Abuse | NCT00375102

Studies
Acupuncture and the Relaxation Response for Substance Abuse

NCT00375102

Sponsor

VA Boston Healthcare System

Status

Completed

Last Update Posted

Dec 15, 2014Estimated

Enrollment

67Actual

Phase

Phase 2Phase 3

Conditions

Substance Abuse

Interventions

Acupuncture
Relaxation Response

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2006

Primary Completion Date

Sep 2007Actual

Completion Date

Nov 2007Actual

First Submitted Date

Sep 11, 2006

First Submission Date that Met QC Criteria

Sep 11, 2006

First Posted Date

Sep 12, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 12, 2014

Last Update Posted Date

Dec 15, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Bei-Hung Chang, Health Research Scientist, VA Boston Healthcare SystemPrincipal Investigator

Lead Sponsor

VA Boston Healthcare SystemFED

Collaborators

Name	Class
Samueli Institute for Information Biology	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

67Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Acup	Experimental	Acupuncture	Procedure: Acupuncture
RR	Experimental	Relaxation Response	Behavioral: Relaxation Response
UC	No Intervention	Usual Care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Acupuncture	Procedure		Acup
Relaxation Response

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in self-reported substance craving rating from baseline to 10 week		baseline and 10 week follow up

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Schizophrenia or psychotic diagnoses
Bleeding disorders (hemophilia or thrombocytopenia)
An allergy to metals (needles).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bei-Hung Chang, Sc.D.	VA Boston Health Care System	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bedford VAMC		Bedford	Massachusetts	01730	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25187049	Result	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.
	Result	Chang BH, Elizabeth Sommers, Lawrence Herz, Acupuncture and relaxation response for substance use disorder recovery, Journal of Substance Use, 2010, 15(6): 390-401.

ID	Term
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

ID	Term
D000529	Complementary Therapies
D013812	Therapeutics