Caffeine and Cocaine

NCT00733993 | Completed Phase 1 Results DMC

• 3 other identifiers: DA09262P50DA009262DPMCDA
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cocaine Dependence

Keywords

substance abuse; cocaine; caffeine; impulsivity

Outcome Measures

Primary Outcomes (5)

• Visual Analog Scale Subjective Rating of Drug Effects

  Visual Analog Scale Rating. Scores range from 0 to 100 with higher scores meaning greater intensity of response being rated.

  Immediately after dose

• Systolic and Diastolic Blood Pressure

  Sitting Blood Pressure

  Average across 7 time points: Immediately after dose and every 30 minutes for 3 hours

• Heart Rate

  Sitting heart rate

  Average across 7 time points: Immediately after dose and every 30 minutes for 3 hours

• Addiction Research Center Inventory Subjective Rating of Drug Effects

  Addiction Research Center Inventory (ARCI 49). T/F scales with 49 items. Includes the following subscales: Morphine-Benzedrine Group (MBG), includes euphoria (0 to +16, higher numbers = more euphoria) Phenobarbital-Chorpromazine-Alcohol Group (PCAG), includes sedation (-3 to +11, higher scores = more sedation) Lysergic Acid Diethylmide Group (LSD) , includes dysphoria and agitation (-4 to +10, higher scores = more dysphoria) Amphetamine Group (A), includes stimulation ( 0 to +11, higher scores = more stimulation) Benzedrine Group (BG), includes energy and "intellectual efficiacy" (+4 to +9, higher scores = more energy)

  Immediately after dose

• Drug Effects Questionnaire Rating of Subjective Ratings of Drug Effects

  Assessments measured using a 4 item Drug Effects Questionnaire (DEQ) Ranges from 0 to 100 with higher numbers showing greater effect for each scale.

  Immediately after dose

Secondary Outcomes (2)

• Probabalistic Feedback Selection Task

  75 minutes after dose

• Saliva Caffeine and Paraxanthine Levels

  30 minutes prior to dose, 30/90/150 minutes post dose.

Study Arms (4)

1 Caffeine 150 mg

EXPERIMENTAL

Caffeine 150 mg

Drug: Caffeine 150 MG

2 Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

3 Amphetamine

EXPERIMENTAL

Amphetamine

Drug: Amphetamine

4 Caffeine 300 mg

EXPERIMENTAL

Caffeine 300 mg

Drug: Caffeine 300 MG

Interventions

Caffeine 150 MG DRUG

Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion

Also known as: Vivarin

1 Caffeine 150 mg

Placebo DRUG

Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion

2 Placebo

Amphetamine DRUG

Across five separate testing days, subjects were administered two placebo doses, 20 mg damphetamine,150 mg caffeine, and 300 mg caffeine in counterbalanced fashion

3 Amphetamine

Caffeine 300 MG DRUG

Across five separate testing days, subjects were administered two placebo doses, 20 mg damphetamine,150 mg caffeine, and 300 mg caffeine in counterbalanced fashion

Also known as: Vivarin

4 Caffeine 300 mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• National Institute on Drug Abuse (NIDA): collaborator
• The University of Texas Health Science Center, Houston: collaborator

Study Sites (1)

The University of Texas Health Science Center, Houston

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Lane SD, Green CE, Schmitz JM, Rathnayaka N, Fang WB, Ferre S, Moeller FG. Comparison of Caffeine and d-amphetamine in Cocaine-Dependent Subjects: Differential Outcomes on Subjective and Cardiovascular Effects, Reward Learning, and Salivary Paraxanthine. J Addict Res Ther. 2014;5(2):176. doi: 10.4172/2155-6105.1000176.

  PMID: 25414797 RESULT

MeSH Terms

Conditions

Cocaine-Related Disorders; Substance-Related Disorders; Impulsive Behavior

Interventions

Caffeine; Amphetamine

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Results Point of Contact

• Title: F. Gerard Moeller
• Organization: Virginia Commonwealth University

fgmoeller@vcu.edu

804-828-4134

Study Officials

• Frederick G Moeller, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor - Division Chair, Addiction Psychiatry

Study Record Dates

• First Submitted: August 12, 2008
• First Posted: August 13, 2008
• Study Start: April 1, 2008
• Primary Completion: July 1, 2011
• Study Completion: October 1, 2011
• Last Updated: March 22, 2017
• Results First Posted: March 22, 2017

Record last verified: 2017-02

Locations

US (1)