Caffeine and Cocaine

Virginia Commonwealth University (VCU)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Cocaine Dependence

Treatments: Drug: Amphetamine; Drug: Caffeine 150 MG; Drug: Placebo; Drug: Caffeine 300 MG

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00733993

DPMCDA

DA09262

P50DA009262 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study is being done to find out if medicines that affect a neurotransmitter (chemical messenger) in the brain called adenosine improve behavioral problems that are related to drug abuse. Another purpose of the study is to find out how genes related to adenosine change how people respond to these medicines. More information about how these medicines change behaviors may be helpful to come up with new treatments for drug abuse.

Full description

Specific Aims:

Aim 1. To characterize the behavioral and subjective effects of acute caffeine administration in cocaine-dependent subjects, using laboratory measures of impulse control, drug discrimination (with d-amphetamine as the training dose), and subjective effects.

Hypotheses related to Aim 1:

1. Subjects will show decreases in impulsivity (delay to reward and response inhibition) after acute oral doses of caffeine compared to placebo.
2. Subjects will show some stimulant-like subjective effects following acute oral doses of caffeine, but not the euphoric effects that would predict abuse potential.

Enrollment: 23 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects who currently meet DSM-IV criteria for cocaine dependence and healthy controls
• At least one cocaine positive urine during screening.
• Current regular consumption of caffeine.
• Female subjects: a negative pregnancy test.

Exclusion criteria

• Current or past DSM-IV Axis I disorder other than substance abuse/ dependence
• Any significant non-psychiatric medical illness requiring ongoing medical treatment or which would preclude treatment with d-amphetamine or caffeine
• Substance dependence other than cocaine within the last 3 months.
• Positive breath alcohol.
• Positive urine drug screen for drugs other than cocaine or THC at the time of behavioral testing
• For female subjects: known pregnancy or a positive pregnancy test or current breast feeding.
• Diagnosis of Adult Attention Deficit Disorder as determined by: a) meeting DSM-IV criteria for childhood ADHD, b) currently has impairing ADHD symptoms, c) ADHD symptoms can not have remitted at any period since childhood.
• HIV positive.
• I.Q. below 70.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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23 participants in 4 patient groups, including a placebo group

1 Caffeine 150 mg

Experimental group

Description:

Caffeine 150 mg

Treatment:

Drug: Caffeine 150 MG

2 Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

3 Amphetamine

Experimental group

Description:

Amphetamine

Treatment:

Drug: Amphetamine

4 Caffeine 300 mg

Experimental group

Description:

Caffeine 300 mg

Treatment:

Drug: Caffeine 300 MG