Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00279604
Other study ID # 01EB0432
Secondary ID
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
Est. primary completion date
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


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT01539525 - Screening to Augment Referral to Treatment- Project START Phase 2
Completed NCT00158249 - Effects of Citicoline on Brain Function and Behavior in Marijuana-Dependent Individuals Phase 2
Completed NCT00842985 - Dronabinol Interactions in Humans N/A
Completed NCT00484302 - Specialized Addiction Treatment Versus Treatment as Usual for Young Patients With Cannabis Abuse and Psychosis N/A
Completed NCT00227903 - Therapeutic Substance Abuse Treatment in Pregnancy - 1 Phase 2
Completed NCT00227864 - A Brief Marijuana Intervention for Adolescent Women - 1 Phase 3
Completed NCT00218478 - Evaluating Responses to Drug-Related Cues Versus Neutral Cues to Understand the Effects of Marijuana Craving - 1 Phase 1
Completed NCT00249509 - Effectiveness of Nefazodone and Bupropion in Treating Marijuana Dependent Individuals Phase 2
Completed NCT03717272 - Effect of AEF0117 on Subjective Effects of Cannabis in CUD Subjects Phase 2
Completed NCT00142961 - Atomoxetine for Treating Marijuana-Abusing Adolescents Who Have Attention Deficit Hyperactivity Disorder Phase 2
Terminated NCT02102230 - CBT-I for Cannabis Use N/A
Completed NCT00580671 - Treatment for Adolescent Marijuana Abuse N/A
Completed NCT00360269 - Atomoxetine Treatment for ADHD and Marijuana Dependence Phase 2
Completed NCT00227916 - Motivational Interviews for Incarcerated Teens - 1 N/A
Completed NCT03154567 - Effects of Stress and Drug-cue Exposure (SCM) Phase 1
Active, not recruiting NCT05322941 - Effect of AEF0117 on Treatment-seeking Patients With Cannabis Use Disorder (CUD) Phase 2
Completed NCT02797990 - Conflict Between Maternal Autonomy and Child Health in Substance-use N/A
Completed NCT01762696 - A Real-time, Contextual Intervention Using Mobile Technology to Reduce Marijuana Use in Youth N/A
Completed NCT03154580 - Marijuana Cue-Reactivity & Seeking Behavior in Regular Cannabis Users Phase 1
Completed NCT00217971 - Dronabinol Treatment for Marijuana Addiction Phase 2