This trial is active, not recruiting.

Conditions alcoholism, substance-related disorders, smoking, chronic disease, malnutrition
Treatment health promotion activities
Sponsor Skane University Hospital
Collaborator Swedish Council for Working Life and Social Research
Start date October 2010
End date March 2017
Trial size 260 participants
Trial identifier NCT01414907, VIP-LU-2011


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
(Active Comparator)
health promotion activities smoking secession
Counselled activities on tobacco smoking secession, diet correlation and physical activities
(No Intervention)

Primary Outcomes

Change from abuser to non-abuser
time frame: 6 weeks, 3, 6, 9, 12 and 24 months

Secondary Outcomes

Health status
time frame: 6 weeks, 3, 6, 9, 12 and 24 months
Quality of life
time frame: 6 weeks, 3,6,9,12 and 24 months
Harm reduction
time frame: 6 weeks, 3,6,9,12 and 24 months
time frame: 24 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - alcohol or drug dependency Exclusion Criteria: - withdrawal of informed consent - missing competence to give informed consent - pregnant or nursing women

Additional Information

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
Principal investigator Hanne Tønnesen, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Skane University Hospital.