Alcohol AddictionQICANCT03589118
Qi Gong as a Method of Craving Reduction in Severe Addict Patients
A study testing Qi Gong sessions in people with Alcohol Addiction and Alcohol Dependence, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
Trial summary
Craving arises in response to an affective tone that is associated with perceptual representations of a sensory object, rather than directly in response to the object. The investigators presume that qi gong functions to decouple pleasant and unpleasant experience from habitual reactions by removing the affective bias… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Addiction, Alcohol Dependence
- What is being tested?
- Qi Gong sessions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 3 sitesFrance
- Study dates
- 4 Oct 2018to Dec 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets DSM 5 criteria for alcohol use disorder and other substance use disorders
- Alcohol is one of the major abused substances if using multiple substances
- Severity of the disorder defines by the necessity of a complex withdrawal hospitalization.
- Used alcohol in the 3 weeks before hospitalization
- Seeks addiction treatment
- Patient willing to adhere to the study protocol (e.g. attend all visits and follow-ups in the next 3 months).
Show all 19Show fewer
- Age ≥ 18
- Negative pregnancy test (βHCG) for women of child bearing potential
- Signed informed consent
- Affiliation to the French health insurance (recipient or assign)
- Oral and written comprehension of the french langage
- Non-inclusion criteria
- Pose a current suicidal risk including active suicidal ideation and suicide attempt in the past 30 days
- Non stabilized severe psychiatric comorbidities such as bipolar disorder, schizophrenia, … (at the investigator's discretion)
- Pregnant or breastfeeding women
- Decompensated cirrhosis, liver encephalopathy, neurological complications, severe cognitive impairment and any other severe somatic comorbidity (at the investigator's discretion)
- Currently participated in other interventional clinical study
- Individuals placed under guardianship
- Patient deprived of freedom
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
France3 sites, 2 recruiting
- Recruiting
Hôpital Saint ELOI
Montpellier, 34000
Hélène DONNADIEU-RIGOLE, MD, PHD, 0467337020 ext. 0033, h-donnadieu_rigole@chu-montpellier.fr
- Active, not recruiting
Hôpital L'ARCHET
Nice, 06002
- Recruiting
Groupe Hospitalier Pitié Salpêtrière
Paris, 75013
Bruno MILLET, MD, PHD, 0142162894 ext. 0033, b.millet@aphp.fr
About this study
Craving arises in response to an affective tone that is associated with perceptual representations of a sensory object, rather than directly in response to the object.
The investigators presume that qi gong functions to decouple pleasant and unpleasant experience from habitual reactions by removing the affective bias that fuels such emotional reactivity. Qi gong training may specifically target the associated learning process with an emphasis on the critical link between affect and craving in an addictive loop.
Read the detailed description
The treatment of severe addiction to alcohol and one other or more psychoactive substances sometimes requires hospitalization for complex withdrawal. The medical term " sevrage complexe " is used in this file for hospitalization of patients with multiple addictions or with multiple comorbidities. In the french regulation the duration of hospitalization for " sevrage complexe " is at least 13 days.
The acute period of the first week is sufficient for physical weaning. A period relay for maintaining abstinence beyond the acute phase is a difficult stage. During this period the psychological craving related to the absence of the product causes dysphoria, stress, emotivity and increased difficulty in managing psychological aggression. The risk of relapse is then maximal and favored by many insults of everyday life.
Qi gong is classified by US National Library of Medicine as a mind-body therapy (MBT). It's an ancient traditional Chinese health practice believed to have special healing and recovery power. Today millions of people practice qi gong in China and around the world to treat various diseases. Qi gong is an ecole of breath, relaxation, guided imagery and inward attention. Practice of qi gong is believed to help cleanse the body of toxins, restore energy balance, reduce stress and anxiety. The Baduanjin qigong is one of the most common form of Chinese qi gong.
When going through withdrawal, craving is a psychological urge to administer a discontinued medication or recreational drug. Craving episodes may be triggered by seeing objects or experiencing moments that are associated with the drug or usage of it, and this phenomenon is termed post-acute withdrawal syndrome.
The main goal of our study is to demonstrate a reduction of craving during alcohol and coaddictions withdrawal. This demonstration is of first importance: first for the well-being of the patient during the first weeks after withdrawal, second for drug savings, and third abstinence rate because many authors consider that craving intensity is correlated with relapses risk.
The mind-body techniques of traditional Chinese medicine, as Qigong, are inscribed the number of current approaches in residential treatment. Their transmission would be an additional contribution to the stabilization via active management and motivated patient himself on his health.
The compulsion associated with addictive behavior can be defined as a pathological change in brain plasticity. The pathological learning process induced by the repeated use of the substance is causing behavioral control loss in the vulnerable individual.
Considering the impulsive nature of craving, this study will investigate the driving dynamics of impulses: Trieb "push". Return to the perception supported by the development of attention gestures leaning on the breath, puts us ahead of the motor action and is potentially a mean of influencing compulsive process.
- Conditions
- Alcohol Addiction, Alcohol Dependence
- Being tested
- Qi Gong sessions
- Keywords
- Substance Addiction, Craving, Chinese Medecine, Qi Gong, Psychology
- Medical subject headings
- Alcoholism, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qi Gong sessionsOther
13 sessions of Qi Gong in a 9 weeks period
| Study group | Role | What they receive |
|---|---|---|
| Qi Gong | Experimental | Qi gong sessions added to usual well defined medical and psychological support Receives: Other: Qi Gong sessions |
| Control | No intervention | Usual well defined medical and psychological support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of craving intensity
Variation of craving intensity on a Vvisual aAnalogic sScale (VAS) between baseline and the end of the treatment. The intensity is measured by "not at all" (score of 0) and "craving as bad as it could be" or "the most I've ever felt " (maximum score of 10), self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents his craving intensity.
The score is determined by measuring the distance on the 10-cm line between the "no craving" anchor and the patient's mark.
Measured: Change in VAS from baseline to 9 weeks treatment
Secondary outcomes (9)
Evolution over time of craving intensity
Craving intensity measured with 14-items Obsessive Compulsive Drinking Scale (OCDS).
OCDS score is the sum of two subscales scores. Obsessive Subscale is calculated from items 1 to 6, maximal subscore is 20 (worse outcome).
Compulsive subscale is calculated from items 7 to 14.
Measured: 0 day, 3 days, 5 days, 3 weeks and 9 weeks post-baseline
Difference in treatment retention
Difference in treatment retention (permanence rate)
Measured: 3 weeks and 9 weeks post-baseline
Evolution over time of total alcohol consumption
Alcohol consumption assessed with Time Line Follow Back (TLFB)
Measured: 0 day, 3 days, 5 days, 3 weeks and 9 weeks post-baseline
Evoluation over time of anxiety
Anxiety questions sum score of Hospital Anxiety and Depression scale (HAD scale). Seven questions are related to anxiety (total A). Anxiety is measured by the sum score questions 1 , 4, 6 , 8, 10 , 12, 14. . Non : Total A = 1,3,5,7,9,11,13
The maximum score being equal to 21 :
0-7: normal; 8-10 bordeline abnormal (borderline case); 11-21 : abnormal (case)
Measured: 0 day, 3 days, 5 days, 3 weeks and 9 weeks post-baseline
Evolution over time of depression
Depression questions sum score of Hospital Anxiety and Depression scale (HAD scale).
Seven questions are related to the depressive dimension (total D). Depression is measured by the sum score questions 2, 3, 5 , 7, 9 , 11, 13 Non: Total D : 2,4,6,8,10,12,14.
The maximum score being equal to 21 :
0-7: normal; 8-10: bordeline abnormal (borderline case); 11-21: abnormal (case)
Measured: 0 day, 3 days, 5 days, 3 weeks and 9 weeks post-baseline
Psycological qualitative evaluation
Qualitative evaluation assessed with clinical notes
Measured: 1 day, 2 days, 3 days, 4 days, 5 days, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks and 9 weeks post-baseline
Evolution over time of total alcohol consumption measured by GGT biomarker
GGT Gamma glutamyl transpeptidase levels in UI/I
Measured: at 0 day, 3 days, 5 days, 3 weeks and 9 weeks post-baseline
Evolution over time of total alcohol consumption measured by Carbohydrate-Deficient Transferrin (CDT) marker
CDT levels in %
Measured: at 0 day, 3 days, 5 days, 3 weeks and 9 weeks post-baseline
Evolution over time of total alcohol consumption measured by Mean Globular Volume (MGV) marker
MGV levels in fL
Measured: at 0 day, 3 days, 5 days, 3 weeks and 9 weeks post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2018
- Study start4 Oct 2018
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol AddictionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Model description
- Patients are randomized in two groups : * usual medical and psychological support in the control group * qi gong sessions added in the experimental group Allocation between groups qi and control is 1 : 1
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alain BAUMELOU, MD, Ph.D, Principal investigator, Assistance Publique - Hôpitaux de ParisNathalie PLET, Ph.D, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03589118
- Sponsor's protocol ID
- P160946J
- Other IDs
- 2017-A02986-47
- Acronym
- QICA
- Status last verified
- Jul 2019
- First submitted
- 18 May 2018
- Last updated
- 17 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qi Gong as a Method of Craving Reduction in Severe Addict Patients
- ClinicalTrials.gov ID
- NCT03589118
- Acronym / sponsor ID
- QICA / P160946J
- Conditions
- Alcohol Addiction, Alcohol Dependence
- Keywords
- Substance Addiction, Craving, Chinese Medecine, Qi Gong, Psychology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 4 Oct 2018 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 17 Jul 2018 (actual)
- 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.
Craving arises in response to an affective tone that is associated with perceptual representations of a sensory object, rather than directly in response to the object.
The investigators presume that qi gong functions to decouple pleasant and unpleasant experience from habitual reactions by removing the affective bias that fuels such emotional reactivity. Qi gong training may specifically target the associated learning process with an emphasis on the critical link between affect and craving in an addictive loop.
Detailed description
The treatment of severe addiction to alcohol and one other or more psychoactive substances sometimes requires hospitalization for complex withdrawal. The medical term " sevrage complexe " is used in this file for hospitalization of patients with multiple addictions or with multiple comorbidities. In the french regulation the duration of hospitalization for " sevrage complexe " is at least 13 days.
The acute period of the first week is sufficient for physical weaning. A period relay for maintaining abstinence beyond the acute phase is a difficult stage. During this period the psychological craving related to the absence of the product causes dysphoria, stress, emotivity and increased difficulty in managing psychological aggression. The risk of relapse is then maximal and favored by many insults of everyday life.
Qi gong is classified by US National Library of Medicine as a mind-body therapy (MBT). It's an ancient traditional Chinese health practice believed to have special healing and recovery power. Today millions of people practice qi gong in China and around the world to treat various diseases. Qi gong is an ecole of breath, relaxation, guided imagery and inward attention. Practice of qi gong is believed to help cleanse the body of toxins, restore energy balance, reduce stress and anxiety. The Baduanjin qigong is one of the most common form of Chinese qi gong.
When going through withdrawal, craving is a psychological urge to administer a discontinued medication or recreational drug. Craving episodes may be triggered by seeing objects or experiencing moments that are associated with the drug or usage of it, and this phenomenon is termed post-acute withdrawal syndrome.
The main goal of our study is to demonstrate a reduction of craving during alcohol and coaddictions withdrawal. This demonstration is of first importance: first for the well-being of the patient during the first weeks after withdrawal, second for drug savings, and third abstinence rate because many authors consider that craving intensity is correlated with relapses risk.
The mind-body techniques of traditional Chinese medicine, as Qigong, are inscribed the number of current approaches in residential treatment. Their transmission would be an additional contribution to the stabilization via active management and motivated patient himself on his health.
The compulsion associated with addictive behavior can be defined as a pathological change in brain plasticity. The pathological learning process induced by the repeated use of the substance is causing behavioral control loss in the vulnerable individual.
Considering the impulsive nature of craving, this study will investigate the driving dynamics of impulses: Trieb "push". Return to the perception supported by the development of attention gestures leaning on the breath, puts us ahead of the motor action and is potentially a mean of influencing compulsive process.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients are randomized in two groups : * usual medical and psychological support in the control group * qi gong sessions added in the experimental group Allocation between groups qi and control is 1 : 1
| Arm | Type | Receives |
|---|---|---|
| Qi Gong | Experimental | Other: Qi Gong sessionsQi gong sessions added to usual well defined medical and psychological support |
| Control | No intervention | –Usual well defined medical and psychological support |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Meets DSM 5 criteria for alcohol use disorder and other substance use disorders
- Alcohol is one of the major abused substances if using multiple substances
- Severity of the disorder defines by the necessity of a complex withdrawal hospitalization.
- Used alcohol in the 3 weeks before hospitalization
- Seeks addiction treatment
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Qi Gong sessions13 sessions of Qi Gong in a 9 weeks period | Other | Qi Gong |
Primary outcome
Variation of craving intensity
Time frame: Change in VAS from baseline to 9 weeks treatment
Variation of craving intensity on a Vvisual aAnalogic sScale (VAS) between baseline and the end of the treatment. The intensity is measured by "not at all" (score of 0) and "craving as bad as it could be" or "the most I've ever felt " (maximum score of 10), self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents his craving intensity. The score is determined by measuring the distance on the 10-cm line between the "no craving" anchor and the patient's mark.
9 secondary outcomes
Evolution over time of craving intensity
Time frame: 0 day, 3 days, 5 days, 3 weeks and 9 weeks post-baseline
Difference in treatment retention
Time frame: 3 weeks and 9 weeks post-baseline
Evolution over time of total alcohol consumption
Time frame: 0 day, 3 days, 5 days, 3 weeks and 9 weeks post-baseline
Evoluation over time of anxiety
Time frame: 0 day, 3 days, 5 days, 3 weeks and 9 weeks post-baseline
Evolution over time of depression
Time frame: 0 day, 3 days, 5 days, 3 weeks and 9 weeks post-baseline
Psycological qualitative evaluation
Time frame: 1 day, 2 days, 3 days, 4 days, 5 days, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks and 9 weeks post-baseline
Evolution over time of total alcohol consumption measured by GGT biomarker
Time frame: at 0 day, 3 days, 5 days, 3 weeks and 9 weeks post-baseline
Evolution over time of total alcohol consumption measured by Carbohydrate-Deficient Transferrin (CDT) marker
Time frame: at 0 day, 3 days, 5 days, 3 weeks and 9 weeks post-baseline
Evolution over time of total alcohol consumption measured by Mean Globular Volume (MGV) marker
Time frame: at 0 day, 3 days, 5 days, 3 weeks and 9 weeks post-baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2019.
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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.
Alain BAUMELOU, MD, Ph.D principal investigator
Assistance Publique - Hôpitaux de Paris
Nathalie PLET, Ph.D study director
Assistance Publique - Hôpitaux de Paris
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Qi Gong sessions in people with Alcohol Addiction and Alcohol Dependence, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
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 19 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 17 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alain BAUMELOU, MD, Ph.D (01 42 16 05 75 ext. 0033, alain.baumelou@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of craving intensity (time frame: Change in VAS from baseline to 9 weeks treatment). 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 17 Jul 2019.