The Role of the Glutamatergic System in the Extinction of Conditioned Reinforcement Processes (SFB636D6)

Central Institute of Mental Health, Mannheim

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Alcohol Drinking

Treatments: Drug: D-cycloserine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00926900

SFB636 D6 2006-007090-72

Details and patient eligibility

About

The aim of this project is to explore whether the extinction of cue-reactivity following a cue-exposure based intervention in volunteers with an alcohol dependence is facilitated by drugs that increase NMDA-receptor function.

It is hypothesised that targeted treatment with D-Cycloserine prior to each extinction training session enhances the effects on cue-reactivity.

Further, a significant correlation between the reduction of cue-reactivity and both reduced craving and relapse probability is expected.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• current DSM-IV/ ICD-10 diagnosis of alcohol dependence
• controlled abstinence for a period of 5 to 21 days following admission to inpatient detoxification or day-clinic care
• women (in childbearing age): use of a highly effective method of contraception
• normal or corrected-to-normal vision
• ability to provide written informed consent

Exclusion criteria

• diagnosis of additional axis I or II disorders (according to DSM-IV( ICD- 10 criteria) either currently or within the past 12 months (except nicotine dependence)
• positive drug screening
• current medication with anti-convulsive or psychotropic drugs
• MRI ineligibility
• sensitivity to study medication as evidenced by a history of adverse drug experience
• severe withdrawal symptoms (e.g. convulsions, delirium)
• disposition towards experiencing convulsions/ epilepsy
• history of schizophrenic disorders/ affective psychosis
• neurological diseases that might affect the dopaminergic, limbic and frontal cortices or extrapyramidal motor functioning
• major diseases (e.g. diabetes, liver cirrhosis, heart disease)
• physical illness interfering with study procedures or affecting study outcomes
• pregnancy (positive test results)/ lactation period
• suicidal tendencies/ increased risk that others might be harmed -

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

D-cycloserine

Active Comparator group

Treatment:

Drug: D-cycloserine

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo