Substance AbusePhase 2/3NCT00375102
Acupuncture and the Relaxation Response for Substance Abuse
A Phase 2/3 study testing Acupuncture and Relaxation Response in people with Substance Abuse, run by VA Boston Healthcare System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Abuse
- What is being tested?
- Acupuncture and Relaxation Response
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Nov 2007
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Schizophrenia or psychotic diagnoses
- Bleeding disorders (hemophilia or thrombocytopenia)
- An allergy to metals (needles).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Substance Abuse
- Being tested
- Acupuncture, Relaxation Response
- Keywords
- acupuncture, relaxation response, homeless, veterans, randomized trials
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
Relaxation ResponseBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Acup | Experimental | Acupuncture Receives: Procedure: Acupuncture |
| RR | Experimental | Relaxation Response Receives: Behavioral: Relaxation Response |
| UC | No intervention | Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in self-reported substance craving rating from baseline to 10 week
Measured: baseline and 10 week follow up
Secondary outcomes (2)
Changes in anxiety level from baseline to 10 week
Measured: baseline and 10 week follow up
Changes in quality of life from baseline to 10 week
Measured: baseline and 10 week follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2006 (estimated)
- Study startNov 2006
- Primary completionSep 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Substance AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Boston Healthcare System
- Sponsor type
- US federal agency
- Collaborators
- Samueli Institute for Information Biology
- Responsible party
- Principal investigator, Bei-Hung Chang, VA Boston Healthcare System
- Investigators
- Bei-Hung Chang, Sc.D., Principal investigator, VA Boston Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00375102
- Sponsor's protocol ID
- 1 EA-0000041
- Status last verified
- Dec 2014
- First submitted
- 11 Sep 2006
- Last updated
- 15 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25187049Chang BH, Elizabeth Sommers, Lawrence Herz, Acupuncture and relaxation response for substance use disorder recovery, Journal of Substance Use, 2010, 15(6): 390-401.
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture and the Relaxation Response for Homeless Veterans With Substance Abuse
- ClinicalTrials.gov ID
- NCT00375102
- Acronym / sponsor ID
- 1 EA-0000041
- Conditions
- Substance Abuse
- Keywords
- acupuncture, relaxation response, homeless, veterans, randomized trials
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- VA Boston Healthcare SystemUS federal agency
- Collaborators
- Samueli Institute for Information Biology
- Study start
- Nov 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 12 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acup | Experimental | Procedure: AcupunctureAcupuncture |
| RR | Experimental | Behavioral: Relaxation ResponseRelaxation Response |
| UC | No intervention | –Usual Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- Schizophrenia or psychotic diagnoses
- Bleeding disorders (hemophilia or thrombocytopenia)
- An allergy to metals (needles).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupuncture | Procedure or surgery | Acup |
| Relaxation Response | Behavioural | RR |
Primary outcome
Changes in self-reported substance craving rating from baseline to 10 week
Time frame: baseline and 10 week follow up
2 secondary outcomes
Changes in anxiety level from baseline to 10 week
Time frame: baseline and 10 week follow up
Changes in quality of life from baseline to 10 week
Time frame: baseline and 10 week follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2014.
- Results publication: PubMed 25187049Chang 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.
- Results publicationChang BH, Elizabeth Sommers, Lawrence Herz, Acupuncture and relaxation response for substance use disorder recovery, Journal of Substance Use, 2010, 15(6): 390-401.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bei-Hung Chang, Sc.D. principal investigator
VA Boston Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Acupuncture and Relaxation Response in people with Substance Abuse, run by VA Boston Healthcare System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in self-reported substance craving rating from baseline to 10 week (time frame: baseline and 10 week follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00375102, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2014.