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Study of Effectiveness of Adding the Health Promotion and Rehabilitation for Treatment for Alcohol and Drug Abusers (VIP)

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ClinicalTrials.gov Identifier: NCT01414907
Recruitment Status : Completed
First Posted : August 11, 2011
Last Update Posted : June 6, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to evaluate the effect of adding the Health Promotion activities and rehabilitation to the usual alcohol and drug interventions on the outcome for alcohol and drug abusers compared to the usual intervention alone.

Condition or disease Intervention/treatment
Alcoholism Substance-Related Disorders Smoking Chronic Disease Malnutrition Behavioral: Health promotion activities

Detailed Description:

Background: Alcohol and drug abuse are followed by tremendous physical, psychological and social problems as well as early death. Heavy smoking, poor nutrition, physical inactivity and chronic diseases (co-morbidity) are often part of these problems and illnesses.

There seems to be a large potential for a better outcome by including smoking cessation, physical training, diet and nutrition as well as co-morbidity in a multi-disciplinary setting - a potential not used yet. This Very Integrated Program (VIP) is inspired from the rehabilitation offered to patients with chronic diseases and surgical patients having a likewise unhealthy lifestyle and similar co-morbidity.

Aim: to evaluate the effect of adding the VIP program to the usual alcohol and drug intervention on the outcome for alcohol and drug abusers compared to the usual intervention alone.

The VIP project consists of 3 steps:

  1. To map the health status and estimate the potential improvement for 400 alcohol and drug abusers
  2. To pilot test the VIP program
  3. To evaluate it compared to the daily routines for 260 alcohol and drug abusers with a poor health status in a randomised controlled trial.

Main outcome: Change from abuser to non-abuser. Secondary outcomes are health status; quality of life, use of health services, time return to work (or similar activity level), harm reduction, and cost-effectiveness.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 214 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: VIP (Very Important Patient) Project on Alcohol and Drug Abusers - RCT of Efficacy of the Adding the Health Promotion and Rehabilitation for Treatment of Alcohol and Drug Abusers
Actual Study Start Date : October 2010
Primary Completion Date : September 2015
Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Health Promotion activities Behavioral: Health promotion activities
Counselled activities on tobacco smoking secession, diet correlation and physical activities
Other Names:
  • smoking secession
  • physical activity
  • diet
No Intervention: No Intervention

Outcome Measures

Primary Outcome Measures :
  1. Change from abuser to non-abuser [ Time Frame: 6 weeks, 3, 6, 9, 12 and 24 months ]

Secondary Outcome Measures :
  1. Health status [ Time Frame: 6 weeks, 3, 6, 9, 12 and 24 months ]
  2. Quality of life [ Time Frame: 6 weeks, 3,6,9,12 and 24 months ]
  3. Harm reduction [ Time Frame: 6 weeks, 3,6,9,12 and 24 months ]
  4. Cost-effectiveness [ Time Frame: 24 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • alcohol or drug dependency

Exclusion Criteria:

  • withdrawal of informed consent
  • missing competence to give informed consent
  • pregnant or nursing women
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01414907

Addiction Center Malmo, Psychiatry Skane, Skane University Hospital
Malmo, Skane, Sweden, 20502
Sponsors and Collaborators
Skane University Hospital
Swedish Council for Working Life and Social Research
The Swedish Council for Information on Alcohol and Other Drugs
Lund University
Copenhagen University Hospital, Denmark
Principal Investigator: Hanne Tønnesen, MD, PhD WHO-CC, Bispebjerg University Hopital, Copenhagen, Denmark
More Information

Additional Information:
Tønnesen H, Hovhannisyan K, Ehrnström M, Skibelund D, Kovacs J, Thornqvist K, Skagert E. Co-morbidity in drug and alcohol addicts - a VIP project. 19th International Conference on Health Promotion Hospitals and Health Services, June 2011, Turku, Finland

Responsible Party: Hanne Tønnesen, Professor, Lund University
ClinicalTrials.gov Identifier: NCT01414907     History of Changes
Other Study ID Numbers: VIP-LU-2011
First Posted: August 11, 2011    Key Record Dates
Last Update Posted: June 6, 2017
Last Verified: June 2017

Keywords provided by Hanne Tønnesen, Lund University:
Drinking Behavior
Harm Reduction
Tobacco Use Cessation
Smoking Cessation
Health Promotion
Nutrition Therapy
Feeding Behavior

Additional relevant MeSH terms:
Chronic Disease
Substance-Related Disorders
Nutrition Disorders
Alcohol-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Disease Attributes
Pathologic Processes