Cocaine DependencePhase 1/2NCT00733993

Caffeine and Cocaine

A Phase 1/2 study testing Caffeine 150 MG, Amphetamine and Caffeine 300 MG in people with Cocaine Dependence, run by Virginia Commonwealth University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Cocaine Dependence
What is being tested?: Caffeine 150 MG, Amphetamine and Caffeine 300 MG
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 23 participants
Where: 1 siteUnited States
Study dates: Apr 2008to Oct 2011
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

Show all 9Show fewer

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 locations and contacts

1 site in 1 country.

United States1 site

The University of Texas Health Science Center, Houston
Houston, Texas, 77030

Other trials in United States

About this study

Official title: Experiment 1: Adenosine Receptor A2A Antagonists and Cocaine Dependence

Read the 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:

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

Conditions: Cocaine Dependence
Being tested: Caffeine 150 MG, Placebo, Amphetamine, Caffeine 300 MG
Keywords: substance abuse, cocaine, caffeine, impulsivity
Medical subject headings: Cocaine-Related Disorders, Substance-Related Disorders, Impulsive Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Caffeine 150 MGDrug
Also called Vivarin
Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion
PlaceboDrug
Across five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion
AmphetamineDrug
Across five separate testing days, subjects were administered two placebo doses, 20 mg damphetamine,150 mg caffeine, and 300 mg caffeine in counterbalanced fashion
Caffeine 300 MGDrug
Also called Vivarin
Across five separate testing days, subjects were administered two placebo doses, 20 mg damphetamine,150 mg caffeine, and 300 mg caffeine in counterbalanced fashion

Study groups in NCT00733993
Study group	Role	What they receive
1 Caffeine 150 mg	Experimental	Caffeine 150 mg Receives: Drug: Caffeine 150 MG
2 Placebo	Placebo comparator	Placebo Receives: Drug: Placebo
3 Amphetamine	Experimental	Amphetamine Receives: Drug: Amphetamine
4 Caffeine 300 mg	Experimental	Caffeine 300 mg Receives: Drug: Caffeine 300 MG

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Immediately after dose
Systolic and Diastolic Blood Pressure
Sitting Blood Pressure
Measured: Average across 7 time points: Immediately after dose and every 30 minutes for 3 hours
Heart Rate
Sitting heart rate
Measured: 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)
Measured: 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.
Measured: Immediately after dose

Secondary outcomes (2)

Probabalistic Feedback Selection Task
Accuracy on a range from 0 to 1 of correctly performing a learning task, with 1 being the highest degree of accuracy.
Measured: 75 minutes after dose
Saliva Caffeine and Paraxanthine Levels
Due to insufficient oral volume or breakage during sample transfer, data were lost or incomplete for two cocaine-dependent subjects.
Analyses for the saliva data represent 11 cocaine-dependent subjects and 10 controls.
Measured: 30 minutes prior to dose, 30/90/150 minutes post dose.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2008Oct 2011

First posted13 Aug 2008 (estimated)
Study startApr 2008
Primary completionJul 2011
Study completionOct 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Cocaine DependenceStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00733993
Sponsor's protocol ID: DA09262
Other IDs: P50DA009262, DPMCDA
Status last verified: Feb 2017
First submitted: 12 Aug 2008
Last updated: 22 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 25414797

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cocaine Dependence trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Experiment 1: Adenosine Receptor A2A Antagonists and Cocaine Dependence
ClinicalTrials.gov ID: NCT00733993
Acronym / sponsor ID: DA09262
Conditions: Cocaine Dependence
Keywords: substance abuse, cocaine, caffeine, impulsivity
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: Virginia Commonwealth UniversityUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA), The University of Texas Health Science Center, Houston
Study start: Apr 2008
Primary completion: Jul 2011 (actual)
Study completion: Oct 2011 (actual)
First posted: 13 Aug 2008 (estimated)
Results: Posted 22 Mar 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Specific Aims:

Hypotheses related to Aim 1:

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

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
1 Caffeine 150 mg	Experimental	Drug: Caffeine 150 MGCaffeine 150 mg
2 Placebo	Placebo comparator	Drug: PlaceboPlacebo
3 Amphetamine	Experimental	Drug: AmphetamineAmphetamine
4 Caffeine 300 mg	Experimental	Drug: Caffeine 300 MGCaffeine 300 mg

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Caffeine 150 MGAlso: VivarinAcross five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion	Drug	1 Caffeine 150 mg
PlaceboAcross five separate testing days, subjects were administered two placebo doses, 20 mg amphetamine, 150 mg caffeine, and 300 mg caffeine in counterbalanced fashion	Drug	2 Placebo
AmphetamineAcross five separate testing days, subjects were administered two placebo doses, 20 mg damphetamine,150 mg caffeine, and 300 mg caffeine in counterbalanced fashion	Drug	3 Amphetamine
Caffeine 300 MGAlso: VivarinAcross five separate testing days, subjects were administered two placebo doses, 20 mg damphetamine,150 mg caffeine, and 300 mg caffeine in counterbalanced fashion	Drug	4 Caffeine 300 mg

Primary outcome

Visual Analog Scale Subjective Rating of Drug Effects
Time frame: Immediately after dose
Visual Analog Scale Rating. Scores range from 0 to 100 with higher scores meaning greater intensity of response being rated.
Systolic and Diastolic Blood Pressure
Time frame: Average across 7 time points: Immediately after dose and every 30 minutes for 3 hours
Sitting Blood Pressure
Heart Rate
Time frame: Average across 7 time points: Immediately after dose and every 30 minutes for 3 hours
Sitting heart rate
Addiction Research Center Inventory Subjective Rating of Drug Effects
Time frame: Immediately after dose
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)
Drug Effects Questionnaire Rating of Subjective Ratings of Drug Effects
Time frame: Immediately after dose
Assessments measured using a 4 item Drug Effects Questionnaire (DEQ) Ranges from 0 to 100 with higher numbers showing greater effect for each scale.

2 secondary outcomes

Probabalistic Feedback Selection Task
Time frame: 75 minutes after dose
Saliva Caffeine and Paraxanthine Levels
Time frame: 30 minutes prior to dose, 30/90/150 minutes post dose.

Results and safety

Results posted to the registry on 22 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cocaine Users	13	13
Control Participants	10	10

Primary outcome: Visual Analog Scale Subjective Rating of Drug Effects

Time frame: Immediately after dose. Mean (Standard Error). Unit: units on a scale

Measure	Placebo n = 23	Caffeine 150 Mg n = 23	Caffeine 300 mg n = 23	Amphetamine 20 mg n = 23
Elation: Control (N=10)	8.65 (5.33)	9.85 (5.32)	13.65 (6.1)	10.43 (4.48)
Elation: Cocaine (N=13)	25.99 (6.01)	32.54 (7.62)	21.65 (5.68)	25.71 (6.42)
Anxious: Control (N=10)	10.15 (5.31)	10.45 (5.69)	8.50 (4.91)	11.68 (4.62)
Anxious: Cocaine (N=13)	19.64 (6.17)	21.35 (6.01)	25.27 (7.12)	21.71 (5.43)
Vigor: Control (N=10)	8.25 (2.06)	8.50 (1.92)	9.78 (1.98)	8.28 (2.01)
Vigor: Cocaine (N=13)	10.42 (1.54)	10.85 (1.59)	9.27 (1.60)	10.31 (1.33)
Tension: Control (N=10)	1.05 (0.38)	1.60 (0.53)	1.62 (0.60)	1.53 (0.48)
Tension: Cocaine (N=13)	1.63 (0.62)	0.96 (0.57)	2.38 (0.94)	1.88 (0.61)

Primary outcome: Systolic and Diastolic Blood Pressure

Time frame: Average across 7 time points: Immediately after dose and every 30 minutes for 3 hours. Mean (Standard Error). Unit: mmHg

Measure	Placebo n = 23	Caffeine 150 Mg n = 23	Caffeine 300 mg n = 23	Amphetamine 20mg n = 23
SBP Control (N=10)	115.64 (3.41)	115.9 (4.07)	117.36 (4.2)	119.27 (2.13)
SBP Cocaine (N=13)	120.18 (1.40)	122.10 (1.81)	123.84 (2.18)	120.30 (1.58)
DBP Control (N=10)	74.82 (2.78)	75.33 (2.72)	77.94 (1.42)	77.83 (1.45)
DBP Cocaine (N=13)	79.66 (3.01)	79.98 (1.79)	82.81 (1.74)	78.16 (1.56)

Primary outcome: Heart Rate

Time frame: Average across 7 time points: Immediately after dose and every 30 minutes for 3 hours. Mean (Standard Error). Unit: Beats per minute

Measure	Placebo n = 23	Caffeine 150 Mg n = 23	Caffeine 300 mg n = 23	Amphetamine 20mg n = 23
Control (N=10)	66.10 (1.88)	62.47 (2.09)	61.33 (1.67)	65.55 (1.23)
Cocaine (N=13)	63.08 (2.11)	62.60 (3.00)	61.57 (1.40)	63.51 (2.99)

Primary outcome: Addiction Research Center Inventory Subjective Rating of Drug Effects

Time frame: Immediately after dose. Mean (Standard Error). Unit: units on a scale

Measure	Placebo n = 23	Caffeine 150 Mg n = 23	Caffeine 300 mg n = 23	Amphetamine 20 mg n = 23
PCAG: Control (N=10)	3.87 (0.82)	3.62 (0.83)	3.52 (0.79)	3.64 (0.71)
PCAG: Cocaine (N=13)	1.95 (0.58)	1.83 (0.68)	2.95 (0.82)	2.43 (0.67)
A: Control (N=10)	3.20 (0.51)	3.60 (0.68)	3.80 (0.59)	3.22 (0.38)
A: Cocaine (N=13)	3.30 (0.51)	3.39 (0.54)	3.19 (0.44)	3.69 (0.45)
BG: Control (N=10)	6.00 (0.39)	6.35 (0.56)	6.05 (0.57)	5.83 (0.36)
BG: Cocaine (N=13)	5.69 (0.34)	5.77 (0.37)	5.07 (0.61)	5.57 (0.51)
MGB: Control (N=10)	4.09 (1.26)	4.34 (1.31)	5.14 (1.37)	4.04 (1.28)
MGB: Cocaine (N=13)	5.29 (1.13)	5.62 (1.23)	4.31 (0.96)	5.18 (1.00)

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
1 Caffeine	0 of 23 (0%)	0 of 23 (0%)	Not reported
2 Placebo	0 of 23 (0%)	0 of 23 (0%)	Not reported
3 Amphetamine	0 of 23 (0%)	0 of 23 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 25414797Lane 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Frederick G Moeller, MD principal investigator

The University of Texas Health Science Center, Houston

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Caffeine 150 MG, Amphetamine and Caffeine 300 MG in people with Cocaine Dependence, run by Virginia Commonwealth University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analog Scale Subjective Rating of Drug Effects (time frame: Immediately after dose). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00733993, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2017.