Clinical trial NCT03589118: Qi Gong as a Method of Craving Reduction in Severe Addict Patients
Official title: Qi Gong as a Method of Craving Reduction in Severe Addict Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alcohol Addiction
Alcohol Dependence
Keywords: Substance Addiction
Craving
Chinese Medecine
Qi Gong
Psychology
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2018-07-17
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Variation of craving intensity
timeFrame: Change in VAS from baseline to 9 weeks treatment
Secondary outcomes:
measure: Evolution over time of craving intensity
timeFrame: 0 day, 3 days, 5 days, 3 weeks and 9 weeks post-baseline
measure: Difference in treatment retention
timeFrame: 3 weeks and 9 weeks post-baseline
measure: Evolution over time of total alcohol consumption
timeFrame: 0 day, 3 days, 5 days, 3 weeks and 9 weeks post-baseline
measure: Evoluation over time of anxiety
timeFrame: 0 day, 3 days, 5 days, 3 weeks and 9 weeks post-baseline
measure: Evolution over time of depression
timeFrame: 0 day, 3 days, 5 days, 3 weeks and 9 weeks post-baseline
measure: Psycological qualitative evaluation
timeFrame: 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
measure: Evolution over time of total alcohol consumption measured by GGT biomarker
timeFrame: at 0 day, 3 days, 5 days, 3 weeks and 9 weeks post-baseline
measure: Evolution over time of total alcohol consumption measured by Carbohydrate-Deficient Transferrin (CDT) marker
timeFrame: at 0 day, 3 days, 5 days, 3 weeks and 9 weeks post-baseline
measure: Evolution over time of total alcohol consumption measured by Mean Globular Volume (MGV) marker
timeFrame: at 0 day, 3 days, 5 days, 3 weeks and 9 weeks post-baseline
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Hôpital Saint ELOI
city: Nice
country: France
facility: Hôpital L'ARCHET
city: Paris
country: France
facility: Groupe Hospitalier Pitié Salpêtrière
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Alain BAUMELOU, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Nathalie PLET, Ph.D
role: STUDY_DIRECTOR
References: