Impulsivity, a risk factor in relapse to substance use disorder: investigating neural substrates before and after pharmacological challenges.

Phase 4

• Conditions: middelenafhankelijkheid (alcohol en cocaine); alcohol addiction; cocaine addiction

• Registration Number: NL-OMON33825
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 108

Inclusion Criteria

1) 18-60 years old, male
2) Current DSM-IV diagnosis of cocaine dependence or alcohol dependence, but recently detoxified and abstinent
3) Control group does not have any history of addictive behaviors
4) Able to sign informed consent and to comply with all study procedures

Exclusion Criteria

1) Currently dependent on cocaine for the alcoholgroup
2) Currently dependent on alcohol for the cocaine group
3) Severe neurological or psychiatric disorders (e.g. major depressive disorder, psychosis, bipolar illness, dementia, or any other diseases that require psychotropic medications)
4) Serious medical illness
5) Known hypersensitivity or allergy to N-acetylcysteine or modafinil, or receiving chronic therapy with medication that could interact adversely with one of the medications under study (antibiotics for example), within 30 days prior to randomization, history of peptic ulceration, asthma.
6) Estimated IQ lower than 85
7) Dutch not as his/her primary language

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome variables are: (a) test performance, (b) craving ratings, (c)<br /><br>fMRI activation patterns, (d) relapse. In addition, DNA samples will be taken<br /><br>in order to investigate different polymorphisms in dopamine receptor genes<br /><br>(DRD2 and DRD4) and the Catechol-O-Methyltransferease (COMT) gene, and<br /><br>polymorphisms in the serotonin transporter gene and the gene encoding for the<br /><br>NMDA receptor subunit NR2A.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>not applicable</p><br>