INCA - Intervention and Neuropsychology in Cannabis Abuse

Marijuana Abuse Clinical Trial

Official title:

Targeted Interventions in Cannabis Abuse: Focus on Decision Making (INCA)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00279604
• Other study ID #: 01EB0432
• Status: Recruiting
• Phase: N/A
• First received: January 18, 2006
• Last updated: April 19, 2007
• Start date: July 2005
• Est. completion date: October 2007

Study information

• Verified date: April 2007
• Source: University Hospital, Bonn
• Contact: Christian G Schuetz, MD MPH
• Phone: +49 228 287 9664
• Email: christian.schütz[@]ukb.uni-bonn.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

INCA (Intervention and Neuropsychology of Cannabis Abuse) is a study combining two research goals. One is to study efficacy of a short intervention the ‘Problem Profile Intervention’, which utilizes individual feedback from a ‘substance problem check-up’. Subjects will randomly receive the ‘Problem Profile Intervention’ or the WHO Brief Intervention, a brief intervention, which has been shown to be efficacious. Currently efficiency studies are under way. The WHO Brief Intervention has been translated into German by our group. In contrast to most other cannabis intervention studies the current study is focussed on cannabis abusers not so much cannabis-dependent subjects. A total of 160 subjects are to be recruited. Half of them will randomly receive either the Problem Profile Intervention or the WHO Brief Intervention (active control). A total of 25% of subjects from each group will be placed on a 3 months waiting list before receiving the intervention (inactive control). Intervention outcome will be assessed three months, six month and 12 months after the intervention. We hypothesize cannabis use to be reduced by 25% by the 'Problem Profile Intervention'. The second aim of the study is to study mechanism of substance abuse. Initial results from own studies and data from other groups point to executive cognitive functions as a subtle but important factor that can be compromised in cannabis users (Verdejo-Garcia et al., 2004; Garavan and Stout, 2005). Using an fMRI-study, we intend to examine a subgroup of our subjects on a specific aspect of executive functioning that has recently received major interest in drug research: Decision-making capability, or risk-taking behaviour, respectively (e.g. Ernst and Paulus, 2005).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: October 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years to 36 Years

Eligibility

Inclusion Criteria:

• ASSIST-Score for cannabis consume = 4 = 26

• german mother tongue (or comparable level)

Exclusion Criteria:

• major current psychiatric disorder (e.g. psychosis)

• addiction to other illegal drugs or alcohol

• recent or current intravenous drug use

• CNS-affecting medication

• current psychotherapy, other treatment for substance use disorder

exclusion criteria for fMRI-part:

• left-handedness

• medication (birth control pill, thyroid gland hormones possible)

• internistic illnesses (hypertension, diabetes, diseases of lungs)

• metallic implants (cardiac pacemaker, ferromagnetic object implanted through surgical intervention or accident, large-area tattoos)

• history of serious trauma

• claustrophobia

• gestation

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Marijuana Abuse

Intervention

Behavioral:
• 'Problem Profile Intervention' vs. WHO-Brief Intervention

Locations

Country	Name	City	State
Germany	Friedrich-Wilhelms-University, Department of Psychiatry	Bonn	NRW
Germany	University of Essen, Department of Psychiatry and Psychotherapy	Essen	NRW

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bonn	German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cannabis consumption,
Primary	motivational change
Secondary	ASSIST-Score