Caffeine and Cocaine

Cocaine Dependence Clinical Trial

Official title:

Experiment 1: Adenosine Receptor A2A Antagonists and Cocaine Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00733993
• Other study ID #: DA09262
• Secondary ID: P50DA009262DPMCD
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 12, 2008
• Last updated: January 5, 2016
• Start date: April 2008
• Est. completion date: October 2011

Study information

• Verified date: January 2016
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

3. Following training doses of placebo and 20 mg d-amphetamine, oral doses of caffeine will be discriminated as being different than 20 mg d-amphetamine and different from placebo.

Aim 2. To determine the effect of a 2-week trial of oral caffeine on laboratory measures of impulsivity and cue reactivity in cocaine dependent subjects.

Hypothesis related to Aim 2:

1. Daily caffeine (600 - 900 mg) treatment will decrease impulsivity (delay to reward and response inhibition) compared to placebo.

2. Daily caffeine (600 - 900 mg) treatment will decrease cocaine related cue reactivity compared to placebo.

Secondary Aims:

Secondary Aim 1. To examine the effect of 2-weeks of treatment with caffeine on cocaine use in cocaine dependent subjects.

Secondary hypothesis 1: Cocaine dependent subjects treated with caffeine will show a significant reduction in cocaine positive urine drug screens compared with cocaine dependent subjects treated with placebo.

Secondary Aim 2. To examine the relationship between gene polymorphisms for the A2A receptor gene and behavioral effects of caffeine Secondary hypothesis 2: Genetic variation in the adenosine A2A receptor gene (ADORA2A) will be associated with the behavioral effects of caffeine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: October 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Subjects who currently meet DSM-IV criteria for cocaine dependence.

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cocaine Dependence
• Cocaine-Related Disorders

Intervention

Drug:
• Caffeine
300 mg for 7 days; then 600 mg for 7 days; then 900 mg for 7 days; followed by a 3 day taper. all dosing three times per day
• Placebo
3 times per day

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center, Houston	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Virginia Commonwealth University	National Institute on Drug Abuse (NIDA), The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	impulsivity		3 weeks of treatment	No
Secondary	cocaine positive urines		3 weeks of treatment	No
Secondary	cue reactivity		3 weeks of treatment	No

External Links

•   Click here for more information about the Treatment Research Clinic at the University of Texas Health Center at Houston