SmokingPhase 1NCT01689168
Chiropractic Treatment With Counseling Versus Counseling Alone for Promoting Smoking Cessation
A Phase 1 study testing Counseling and Chiropractic adjustment in people with Smoking, run by Southern California University of Health Sciences at 1 site in United States.
Trial summary
Tobacco use is the number one killer of Americans today. Most current smokers have tried and failed to quit at least once. Smokers are addicted to the nicotine in tobacco products, and withdrawal from smoking can lead to physical symptoms such as irritability, anxiety, nervousness, depression and insomnia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- Counseling and Chiropractic adjustment
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to May 2014
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults 18 yrs and above
- Smokers with desire to quit smoking
Who cannot join
- Received chiropractic treatment or other manipulative therapies within the last month
- Have received any therapy for smoking cessation during the last month
- Visceral, systemic or joint inflammatory disease
- A history of low back surgery
- Osteoporosis
- Prolonged systemic corticosteroid medication
- Pregnancy
- Recent spinal fracture
Trial locations and contacts
1 site in 1 country.
United States1 site
University Health Center - Whittier
Whittier, California, 90604
About this study
Official title: Chiropractic Treatment With Counseling Versus Counseling Alone for Promoting Smoking Cessation: A Randomized Clinical Trial
Tobacco use is the number one killer of Americans today. Most current smokers have tried and failed to quit at least once. Smokers are addicted to the nicotine in tobacco products, and withdrawal from smoking can lead to physical symptoms such as irritability, anxiety, nervousness, depression and insomnia.
This study will examine the effects of tobacco cessation counseling and chiropractic treatments on smokers who desire to quit.
- Conditions
- Smoking
- Being tested
- Counseling, Chiropractic adjustment
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CounselingBehavioural
Tobacco cessation counseling
Chiropractic adjustmentProcedure or surgery
Full spine high velocity, low amplitude manipulation of the spine
| Study group | Role | What they receive |
|---|---|---|
| Counseling plus chiropractic adjustments | Experimental | Not described Receives: Behavioral: Counseling; Procedure: Chiropractic adjustment |
| Counseling alone | Active comparator | Not described Receives: Behavioral: Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tobacco cessation
Has the subject quit smoking?
Measured: Smoking diary will be complete for 3 months
Urinary cotinine
An urinary test for nicotine metabolites
Measured: Baseline, 14, 30, 60 and 90 days
Secondary outcomes (2)
Blood pressure
Measured: Baseline, 14, 30, 60 days
Weight
Measured: Baseline, 14, 30, 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2013
- Study completionMay 2014
Why it stopped: Funding ran out
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern California University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KevinRose, Southern California University of Health Sciences
- Investigators
- Kevin A Rose, DC, MPH, Principal investigator, Southern California University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01689168
- Sponsor's protocol ID
- ROSE004
- Status last verified
- May 2015
- First submitted
- 5 Jun 2012
- Last updated
- 20 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chiropractic Treatment With Counseling Versus Counseling Alone for Promoting Smoking Cessation: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01689168
- Acronym / sponsor ID
- ROSE004
- Conditions
- Smoking
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding ran out
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Southern California University of Health SciencesUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 21 Sep 2012 (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.
Tobacco use is the number one killer of Americans today. Most current smokers have tried and failed to quit at least once. Smokers are addicted to the nicotine in tobacco products, and withdrawal from smoking can lead to physical symptoms such as irritability, anxiety, nervousness, depression and insomnia.
This study will examine the effects of tobacco cessation counseling and chiropractic treatments on smokers who desire to quit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Counseling plus chiropractic adjustments | Experimental | Behavioral: Counseling, Procedure: Chiropractic adjustment |
| Counseling alone | Active comparator | Behavioral: Counseling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults 18 yrs and above
- Smokers with desire to quit smoking
Key exclusion criteria (8 listed)
- Received chiropractic treatment or other manipulative therapies within the last month
- Have received any therapy for smoking cessation during the last month
- Visceral, systemic or joint inflammatory disease
- A history of low back surgery
- Osteoporosis
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 |
|---|---|---|
| CounselingTobacco cessation counseling | Behavioural | Counseling alone, Counseling plus chiropractic adjustments |
| Chiropractic adjustmentFull spine high velocity, low amplitude manipulation of the spine | Procedure or surgery | Counseling plus chiropractic adjustments |
Primary outcome
Tobacco cessation
Time frame: Smoking diary will be complete for 3 months
Has the subject quit smoking?
Urinary cotinine
Time frame: Baseline, 14, 30, 60 and 90 days
An urinary test for nicotine metabolites
2 secondary outcomes
Blood pressure
Time frame: Baseline, 14, 30, 60 days
Weight
Time frame: Baseline, 14, 30, 60 days
Results and safety
The study was stopped early (reason given: Funding ran out). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2015.
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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.
Kevin A Rose, DC, MPH principal investigator
Southern California University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Counseling and Chiropractic adjustment in people with Smoking, run by Southern California University of Health Sciences 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 8 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: stopped early, as of the sponsor's last update on 20 May 2015. 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 phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: Funding ran out). Results are not available in the source record.
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?
Tobacco cessation (time frame: Smoking diary will be complete for 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 May 2015.