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

Not Applicable

• Conditions: Alcohol Addiction; Alcohol Dependence
• Interventions: Other: Qi Gong sessions

• Registration Number: NCT03589118
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2018-05-18
• Study First Submitted QC: 2018-07-16
• Study First Posted: 2018-07-17
• Study Start: 2018-10-04
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-15
• Last Update Posted: 2019-07-17
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 186

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Qi Gong	Qi Gong sessions	Qi gong sessions added to usual well defined medical and psychological support

Primary Outcome Measures

Name	Time	Method
Variation of craving intensity	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.

Secondary Outcome Measures

Name	Time	Method
Evolution over time of total alcohol consumption measured by Carbohydrate-Deficient Transferrin (CDT) marker	at 0 day, 3 days, 5 days, 3 weeks and 9 weeks post-baseline	CDT levels in %
Evolution over time of total alcohol consumption measured by Mean Globular Volume (MGV) marker	at 0 day, 3 days, 5 days, 3 weeks and 9 weeks post-baseline	MGV levels in fL
Difference in treatment retention	3 weeks and 9 weeks post-baseline	Difference in treatment retention (permanence rate)
Psycological qualitative evaluation	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	Qualitative evaluation assessed with clinical notes
Evolution over time of total alcohol consumption measured by GGT biomarker	at 0 day, 3 days, 5 days, 3 weeks and 9 weeks post-baseline	GGT Gamma glutamyl transpeptidase levels in UI/I
Evolution over time of craving intensity	0 day, 3 days, 5 days, 3 weeks and 9 weeks post-baseline	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.
Evolution over time of total alcohol consumption	0 day, 3 days, 5 days, 3 weeks and 9 weeks post-baseline	Alcohol consumption assessed with Time Line Follow Back (TLFB)
Evoluation over time of anxiety	0 day, 3 days, 5 days, 3 weeks and 9 weeks post-baseline	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	0 day, 3 days, 5 days, 3 weeks and 9 weeks post-baseline	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)

Trial Locations

Locations (3)

Hôpital Saint ELOI; 🇫🇷 Montpellier, France

Hôpital L'ARCHET; 🇫🇷 Nice, France

Groupe Hospitalier Pitié Salpêtrière; 🇫🇷 Paris, France