Caffeine and Cocaine

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
F. Gerald Moeller, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00733993
First received: August 12, 2008
Last updated: May 3, 2013
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Cocaine Dependence
Drug: Caffeine
Drug: Placebo
Phase 1
Phase 2

Study Type: Interventional
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
Official Title: Experiment 1: Adenosine Receptor A2A Antagonists and Cocaine Dependence

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • impulsivity [ Time Frame: 3 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • cocaine positive urines [ Time Frame: 3 weeks of treatment ] [ Designated as safety issue: No ]
  • cue reactivity [ Time Frame: 3 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment: 67
Study Start Date: April 2008
Study Completion Date: October 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Caffeine
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
Other Name: Vivarin
Placebo Comparator: 2
Placebo
Drug: Placebo
3 times per day
Other Name: Placebo

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00733993

Locations
United States, Texas
The University of Texas Health Science Center, Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Frederick G Moeller, MD The University of Texas Health Science Center, Houston
  More Information

No publications provided

Responsible Party: F. Gerald Moeller, Professor - PSY-Behavioral Sciences, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00733993     History of Changes
Other Study ID Numbers: DA09262, P50DA009262, P50 DA009262, DPMCDA
Study First Received: August 12, 2008
Last Updated: May 3, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
substance abuse
cocaine
caffeine
impulsivity

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Caffeine
Cocaine
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Cardiovascular Agents
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on August 21, 2014