AddictionNCT02153775
Progressive Muscle Relaxation and Cigarette Craving
A study testing Progressive Muscle Relaxation in people with Addiction, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
Cigarette craving usually occurs with unpleasant feelings, including stress. Progressive Muscle Relaxation (PMR) may reduce level of cigarette craving and/or withdrawal symptoms. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Addiction
- What is being tested?
- Progressive Muscle Relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteThailand
- Study dates
- Aug 2012to Nov 2012
- Phase
- Interventional
- 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
- Age 18 years or more
- Daily cigarette smokers
Who cannot join
- Hospitalization
- Participating in cigarette dependency treatment or trying to quit smoking with other methods
- Uncontrolled blood pressure
- Current other substance users (except alcohol)
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Psychiatry, Faculty of Medicine, Chulalongkorn University
Bangkok, Bangkok, 10330
About this study
Official title: Preliminary Study of Effects of Progressive Muscle Relaxation on Cigarette Craving and Withdrawal Symptoms of Experienced Smokers in Acute Cigarette Abstinence : A Randomised Control Trial
Cigarette craving usually occurs with unpleasant feelings, including stress. Progressive Muscle Relaxation (PMR) may reduce level of cigarette craving and/or withdrawal symptoms.
Read the detailed description
The study reports on a study investigating the acute effects of a one-time application of progressive muscle relaxation on craving for cigarettes in smokers who were instructed to abstain from cigarettes for 3 hours.
- Conditions
- Addiction
- Being tested
- Progressive Muscle Relaxation
- Keywords
- Progressive muscle relaxation, Cigarette, Smoking, Craving
- Medical subject headings
- Behavior, Addictive, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Muscle RelaxationBehavioural
Comparison of progressive muscle relaxation and no intervention (e.g., reading newspaper of the day) for the same amount of time.
| Study group | Role | What they receive |
|---|---|---|
| Progressive muscle relaxation | Experimental | Progressive muscle relaxation: single 20-minutes session Receives: Behavioral: Progressive Muscle Relaxation |
| Reading newspaper of the day | No intervention | Reading newspaper of the day : single 20-minutes session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Craving
Craving, a strong desire for using a substance when abstaining from substance, was measured by the Penn Alcohol Rating Scale - adapted (PACS-adapted) and the Visual Analog Scale (VAS).
Measured: Immediately after a 20-minutes session of progressive muscle relaxation
Secondary outcomes (1)
Cigarette withdrawal-related and non-withdrawal related feelings
Cigarette withdrawal symptoms (i.e., anxious, hungry, feeling bad, restless) and non-withdrawal (i.e., high, stimulated, paranoid, tongue - tied) (59-61), as measured by using the Visual Analog Scale (VAS)
Measured: Immediately after a 20-minutes session of progressive muscle relaxation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study startAug 2012
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AddictionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rasmon Kalayasiri, Chulalongkorn University
- Investigators
- Thatsanee Limsanon, M.Sc., Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02153775
- Sponsor's protocol ID
- IRB031/55
- Status last verified
- May 2014
- First submitted
- 26 May 2014
- Last updated
- 3 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Limsanon T, Kalayasiri R. Preliminary effects of progressive muscle relaxation on cigarette craving and withdrawal symptoms in experienced smokers in acute cigarette abstinence: a randomized controlled trial. Behav Ther. 2015 Mar;46(2):166-76. doi: 10.1016/j.beth.2014.10.002. Epub 2014 Nov 7.
PubMed 25645166
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Study of Effects of Progressive Muscle Relaxation on Cigarette Craving and Withdrawal Symptoms of Experienced Smokers in Acute Cigarette Abstinence : A Randomised Control Trial
- ClinicalTrials.gov ID
- NCT02153775
- Acronym / sponsor ID
- IRB031/55
- Conditions
- Addiction
- Keywords
- Progressive muscle relaxation, Cigarette, Smoking, Craving
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 3 Jun 2014 (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.
Cigarette craving usually occurs with unpleasant feelings, including stress. Progressive Muscle Relaxation (PMR) may reduce level of cigarette craving and/or withdrawal symptoms.
Detailed description
The study reports on a study investigating the acute effects of a one-time application of progressive muscle relaxation on craving for cigarettes in smokers who were instructed to abstain from cigarettes for 3 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progressive muscle relaxation | Experimental | Behavioral: Progressive Muscle RelaxationProgressive muscle relaxation: single 20-minutes session |
| Reading newspaper of the day | No intervention | –Reading newspaper of the day : single 20-minutes session |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 years or more
- Daily cigarette smokers
Key exclusion criteria (4 listed)
- Hospitalization
- Participating in cigarette dependency treatment or trying to quit smoking with other methods
- Uncontrolled blood pressure
- Current other substance users (except alcohol)
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 |
|---|---|---|
| Progressive Muscle RelaxationComparison of progressive muscle relaxation and no intervention (e.g., reading newspaper of the day) for the same amount of time. | Behavioural | Progressive muscle relaxation |
Primary outcome
Craving
Time frame: Immediately after a 20-minutes session of progressive muscle relaxation
Craving, a strong desire for using a substance when abstaining from substance, was measured by the Penn Alcohol Rating Scale - adapted (PACS-adapted) and the Visual Analog Scale (VAS).
1 secondary outcome
Cigarette withdrawal-related and non-withdrawal related feelings
Time frame: Immediately after a 20-minutes session of progressive muscle relaxation
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 3 Jun 2014.
- Derived from this study: PubMed 25645166Limsanon T, Kalayasiri R. Preliminary effects of progressive muscle relaxation on cigarette craving and withdrawal symptoms in experienced smokers in acute cigarette abstinence: a randomized controlled trial. Behav Ther. 2015 Mar;46(2):166-76. doi: 10.1016/j.beth.2014.10.002. Epub 2014 Nov 7.
- Thesis descriptionLink provided by the sponsor.
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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.
Thatsanee Limsanon, M.Sc. principal investigator
Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive Muscle Relaxation in people with Addiction, run by Chulalongkorn University at 1 site in Thailand.
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 4 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 3 Jun 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 Thailand. 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.
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?
Craving (time frame: Immediately after a 20-minutes session of progressive muscle relaxation). 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 NCT02153775, which also lists 1 linked publication.
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 3 Jun 2014.