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Qi Gong as a Method of Craving Reduction in Severe Addict Patients (QICA)

Primary Purpose

Alcohol Addiction, Alcohol Dependence

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Qi Gong sessions
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Addiction focused on measuring Substance Addiction, Craving, Chinese Medecine, Qi Gong, Psychology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

  • 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).
  • 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

Sites / Locations

  • Hôpital Saint ELOIRecruiting
  • Hôpital L'ARCHET
  • Groupe Hospitalier Pitié SalpêtrièreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Qi Gong

Control

Arm Description

Qi gong sessions added to usual well defined medical and psychological support

Usual well defined medical and psychological support

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Difference in treatment retention
Difference in treatment retention (permanence rate)
Evolution over time of total alcohol consumption
Alcohol consumption assessed with Time Line Follow Back (TLFB)
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)
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)
Psycological qualitative evaluation
Qualitative evaluation assessed with clinical notes
Evolution over time of total alcohol consumption measured by GGT biomarker
GGT Gamma glutamyl transpeptidase levels in UI/I
Evolution over time of total alcohol consumption measured by Carbohydrate-Deficient Transferrin (CDT) marker
CDT levels in %
Evolution over time of total alcohol consumption measured by Mean Globular Volume (MGV) marker
MGV levels in fL

Full Information

First Posted
May 18, 2018
Last Updated
July 15, 2019
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT03589118
Brief Title
Qi Gong as a Method of Craving Reduction in Severe Addict Patients
Acronym
QICA
Official Title
Qi Gong as a Method of Craving Reduction in Severe Addict Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 4, 2018 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Addiction, Alcohol Dependence
Keywords
Substance Addiction, Craving, Chinese Medecine, Qi Gong, Psychology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
Primary outcome (VAS scale) will be presented to the patient and reported by a study nurse blinded of the randomization arm of the patient.
Allocation
Randomized
Enrollment
186 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Qi Gong
Arm Type
Experimental
Arm Description
Qi gong sessions added to usual well defined medical and psychological support
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual well defined medical and psychological support
Intervention Type
Other
Intervention Name(s)
Qi Gong sessions
Intervention Description
13 sessions of Qi Gong in a 9 weeks period
Primary Outcome Measure Information:
Title
Variation of craving intensity
Description
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.
Time Frame
Change in VAS from baseline to 9 weeks treatment
Secondary Outcome Measure Information:
Title
Evolution over time of craving intensity
Description
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.
Time Frame
0 day, 3 days, 5 days, 3 weeks and 9 weeks post-baseline
Title
Difference in treatment retention
Description
Difference in treatment retention (permanence rate)
Time Frame
3 weeks and 9 weeks post-baseline
Title
Evolution over time of total alcohol consumption
Description
Alcohol consumption assessed with Time Line Follow Back (TLFB)
Time Frame
0 day, 3 days, 5 days, 3 weeks and 9 weeks post-baseline
Title
Evoluation over time of anxiety
Description
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)
Time Frame
0 day, 3 days, 5 days, 3 weeks and 9 weeks post-baseline
Title
Evolution over time of depression
Description
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)
Time Frame
0 day, 3 days, 5 days, 3 weeks and 9 weeks post-baseline
Title
Psycological qualitative evaluation
Description
Qualitative evaluation assessed with clinical notes
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
Title
Evolution over time of total alcohol consumption measured by GGT biomarker
Description
GGT Gamma glutamyl transpeptidase levels in UI/I
Time Frame
at 0 day, 3 days, 5 days, 3 weeks and 9 weeks post-baseline
Title
Evolution over time of total alcohol consumption measured by Carbohydrate-Deficient Transferrin (CDT) marker
Description
CDT levels in %
Time Frame
at 0 day, 3 days, 5 days, 3 weeks and 9 weeks post-baseline
Title
Evolution over time of total alcohol consumption measured by Mean Globular Volume (MGV) marker
Description
MGV levels in fL
Time Frame
at 0 day, 3 days, 5 days, 3 weeks and 9 weeks post-baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria 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). 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alain BAUMELOU, MD, Ph.D
Phone
01 42 16 05 75
Ext
0033
Email
alain.baumelou@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Nathalie PLET, Ph.D
Phone
01 42 16 05 75
Ext
0033
Email
nathalie.plet@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alain BAUMELOU, MD, Ph.D
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nathalie PLET, Ph.D
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Study Director
Facility Information:
Facility Name
Hôpital Saint ELOI
City
Montpellier
ZIP/Postal Code
34000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hélène DONNADIEU-RIGOLE, MD, PHD
Phone
0467337020
Ext
0033
Email
h-donnadieu_rigole@chu-montpellier.fr
Facility Name
Hôpital L'ARCHET
City
Nice
ZIP/Postal Code
06002
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Groupe Hospitalier Pitié Salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruno MILLET, MD, PHD
Phone
0142162894
Ext
0033
Email
b.millet@aphp.fr

12. IPD Sharing Statement

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Qi Gong as a Method of Craving Reduction in Severe Addict Patients

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