Cocaine DependencePhase 2NCT01778010

Modafinil for Smoked Cocaine Self-Administration

A Phase 2 study testing Modafinil 0 mg, Modafinil 200 mg and Modafinil 400 mg in people with Cocaine Dependence, run by New York State Psychiatric Institute 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

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Trial summary

Who is it for?: Ages 21 to 50 years
Conditions the study is for: Cocaine Dependence
What is being tested?: Modafinil 0 mg, Modafinil 200 mg and Modafinil 400 mg
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 8 participants
Where: 1 siteUnited States
Study dates: Mar 2009to Jun 2013
Phase: Phase 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 21 to 50 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Smokes cocaine
Has patterns of smoked cocaine use in terms of frequency and amount which parallel or exceed those administered in the study.
Age 21-50.
Able to give informed consent, and comply with study procedures.
Normal body weight Within normal weight range (for appropriate frame) according to 1983 Metropolitan Weight tables -

Who cannot join

Current seizure disorder, heart disease or a history of serious adverse effects due to cocaine.
Dependence on substances (other than cocaine or nicotine) or a history of dependence on alcohol
Request for drug treatment
Judged to be noncompliant with study protocol.
Current use of any psychotropic medication.
Clinical laboratory tests outside normal limits that are clinically unacceptable to the study physician (BP > 140/90; BUN, creatinine, LFTs > 3x ULN; hematocrit < 34 for women, < 36 for men; pseudocholinesterase deficiency)

Show all 9Show fewer

History of myocardial infarction or ischemia, clinically significant left ventricular hypertrophy, angina, clinically significant arrhythmia, or mitral valve prolapse
Currently meeting DSM-IV criteria for all major psychiatric/psychotic disorders other than transient psychosis due to drug abuse
Current parole or probation Self-report during interview -

Trial locations and contacts

1 site in 1 country.

United States1 site

Columbia University Medical Center
New York, New York, 10032

Other trials in United States

About this study

Official title: Modafinil in a Human Laboratory Model of Cocaine Relapse

Modafinil has been reported to reduce cocaine use in a clinical sample of infrequent users (2 days/week), but the effects of modafinil on cocaine self-administration in the laboratory have not been studied. The present study investigated the effects of modafinil maintenance on cocaine self-administration by frequent users (4 days/week) under controlled laboratory conditions. During this 48-day double-blind, crossover design study, the effects of modafinil maintenance (0, 200, and 400mg/day) on response to smoked cocaine (0, 12, 25, and 50 mg) were examined in nontreatment seeking cocaine-dependent individuals (n = 8).

Conditions: Cocaine Dependence
Being tested: Modafinil 0 mg, Modafinil 200 mg, Modafinil 400 mg, Cocaine 0 mg, Cocaine 12 mg
Keywords: cocaine, modafinil, self-administration, DRD4
Medical subject headings: Cocaine-Related Disorders

What participants receive

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

Modafinil 0 mgDrug
Modafinil (0 mg/day)
Modafinil 200 mgDrug
Modafinil (200 mg/day)
Modafinil 400 mgDrug
Modafinil (400 mg/day)
Cocaine 0 mgDrug
Cocaine (0 mg/day)
Cocaine 12 mgDrug
Cocaine (12 mg/day)
Cocaine 25 mgDrug
Cocaine (25 mg/day)
Cocaine 50 mgDrug
Cocaine (50 mg/day)

Study groups in NCT01778010
Study group	Role	What they receive
Modafinil 0mg + Cocaine 0, 12, 25, 50 mg	Placebo comparator	Participants were maintained on modafinil (0 mg/day) for 15 days, and underwent a dose response of cocaine. Receives: Drug: Modafinil 0 mg; Drug: Cocaine 0 mg; Drug: Cocaine 12 mg; Drug: Cocaine 25 mg; Drug: Cocaine 50 mg
Modafinil 200mg + Cocaine 0, 12, 25, 50 mg	Experimental	Participants were maintained on modafinil (200 mg/day) for 15 days, and underwent a dose response of cocaine. Receives: Drug: Modafinil 200 mg; Drug: Cocaine 0 mg; Drug: Cocaine 12 mg; Drug: Cocaine 25 mg; Drug: Cocaine 50 mg
Modafinil 400mg + Cocaine 0, 12, 25, 50 mg	Experimental	Participants were maintained on modafinil (400 mg/day) for 15 days, and underwent a dose response of cocaine. Receives: Drug: Modafinil 400 mg; Drug: Cocaine 0 mg; Drug: Cocaine 12 mg; Drug: Cocaine 25 mg; Drug: Cocaine 50 mg

What is being measured

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

Cocaine Self-administration
The number of purchased cocaine doses as a function of cocaine dose and modafinil maintenance condition.
Measured: 48 days

Secondary outcomes (2)

Drug Quality Cluster
Visual analogue scale ratings on the 'Drug Quality' cluster as a function of cocaine dose and modafinil maintenance condition. A cluster score was derived by taking the arithmetic average of the items in the cluster. Scores range from 0-100, with higher scores indicating greater agreement with the term. The "Drug Quality Cluster" consisted of three items:
1. "the choice was of high quality"
2. "the choice was potent"
3. "I liked the choice" Higher scores indicate increasing agreement with the statement, which would indicate a poorer outcome.
Measured: 48 days
Heart Rate
Values for heart rate as a function of cocaine dose and modafinil maintenance condition.
Measured: 48 days

Timeline

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

Mar 2009Jun 2013

First posted29 Jan 2013 (estimated)
Study startMar 2009
Primary completionMar 2013
Study completionJun 2013

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.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01778010
Sponsor's protocol ID: 5738
Other IDs: R01DA023650
Status last verified: Dec 2017
First submitted: 24 Jan 2013
Last updated: 9 Jan 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Modafinil in a Human Laboratory Model of Cocaine Relapse
ClinicalTrials.gov ID: NCT01778010
Acronym / sponsor ID: 5738
Conditions: Cocaine Dependence
Keywords: cocaine, modafinil, self-administration, DRD4
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: New York State Psychiatric InstituteUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: Mar 2009
Primary completion: Mar 2013 (actual)
Study completion: Jun 2013 (actual)
First posted: 29 Jan 2013 (estimated)
Results: Posted 9 Jan 2018

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Modafinil 0mg + Cocaine 0, 12, 25, 50 mg	Placebo comparator	Drug: Modafinil 0 mg, Drug: Cocaine 0 mg, Drug: Cocaine 12 mg, Drug: Cocaine 25 mg, Drug: Cocaine 50 mgParticipants were maintained on modafinil (0 mg/day) for 15 days, and underwent a dose response of cocaine.
Modafinil 200mg + Cocaine 0, 12, 25, 50 mg	Experimental	Drug: Modafinil 200 mg, Drug: Cocaine 0 mg, Drug: Cocaine 12 mg, Drug: Cocaine 25 mg, Drug: Cocaine 50 mgParticipants were maintained on modafinil (200 mg/day) for 15 days, and underwent a dose response of cocaine.
Modafinil 400mg + Cocaine 0, 12, 25, 50 mg	Experimental	Drug: Modafinil 400 mg, Drug: Cocaine 0 mg, Drug: Cocaine 12 mg, Drug: Cocaine 25 mg, Drug: Cocaine 50 mgParticipants were maintained on modafinil (400 mg/day) for 15 days, and underwent a dose response of cocaine.

Who may qualify

Ages: 21 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Smokes cocaine
Has patterns of smoked cocaine use in terms of frequency and amount which parallel or exceed those administered in the study.
Age 21-50.
Able to give informed consent, and comply with study procedures.
Normal body weight Within normal weight range (for appropriate frame) according to 1983 Metropolitan Weight tables -

Key exclusion criteria (9 listed)

Current seizure disorder, heart disease or a history of serious adverse effects due to cocaine.
Dependence on substances (other than cocaine or nicotine) or a history of dependence on alcohol
Request for drug treatment
Judged to be noncompliant with study protocol.
Current use of any psychotropic medication.

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
Modafinil 0 mgModafinil (0 mg/day)	Drug	Modafinil 0mg + Cocaine 0, 12, 25, 50 mg
Modafinil 200 mgModafinil (200 mg/day)	Drug	Modafinil 200mg + Cocaine 0, 12, 25, 50 mg
Modafinil 400 mgModafinil (400 mg/day)	Drug	Modafinil 400mg + Cocaine 0, 12, 25, 50 mg
Cocaine 0 mgCocaine (0 mg/day)	Drug	Modafinil 0mg + Cocaine 0, 12, 25, 50 mg, Modafinil 200mg + Cocaine 0, 12, 25, 50 mg, Modafinil 400mg + Cocaine 0, 12, 25, 50 mg
Cocaine 12 mgCocaine (12 mg/day)	Drug	Modafinil 0mg + Cocaine 0, 12, 25, 50 mg, Modafinil 200mg + Cocaine 0, 12, 25, 50 mg, Modafinil 400mg + Cocaine 0, 12, 25, 50 mg
Cocaine 25 mgCocaine (25 mg/day)	Drug	Modafinil 0mg + Cocaine 0, 12, 25, 50 mg, Modafinil 200mg + Cocaine 0, 12, 25, 50 mg, Modafinil 400mg + Cocaine 0, 12, 25, 50 mg
Cocaine 50 mgCocaine (50 mg/day)	Drug	Modafinil 0mg + Cocaine 0, 12, 25, 50 mg, Modafinil 200mg + Cocaine 0, 12, 25, 50 mg, Modafinil 400mg + Cocaine 0, 12, 25, 50 mg

Primary outcome

Cocaine Self-administration
Time frame: 48 days
The number of purchased cocaine doses as a function of cocaine dose and modafinil maintenance condition.

2 secondary outcomes

Drug Quality Cluster
Time frame: 48 days
Heart Rate
Time frame: 48 days

Results and safety

Results posted to the registry on 9 Jan 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Modafinil + Cocaine	13	8

Primary outcome: Cocaine Self-administration

Time frame: 48 days. Mean (Standard Error). Unit: Number of doses purchased

Measure	Modafinil 0mg + Cocaine 0mg n = 8	Modafinil 200mg + Cocaine 0mg n = 8	Modafinil 400mg + Cocaine 0mg n = 8	Modafinil 0mg + Cocaine 12mg n = 8	Modafinil 200mg + Cocaine 12mg n = 8	Modafinil 400mg + Cocaine 12mg n = 8	Modafinil 0mg + Cocaine 25mg n = 8	Modafinil 200mg + Cocaine 25mg n = 8	Modafinil 400mg + Cocaine 25mg n = 8	Modafinil 0mg + Cocaine 50mg n = 8	Modafinil 200mg + Cocaine 50mg n = 8	Modafinil 400mg + Cocaine 50mg n = 8
Value	0 (0)	0 (0)	0 (0)	2.2 (0.3)	1.5 (0.3)	2.1 (0.1)	4.1 (0.2)	2.5 (0.3)	2.6 (0.3)	4.5 (0.1)	3.5 (0.3)	3 (0.3)

Population analysed: Eight patients contributed to each condition, in a within-subjects manner.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 48 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Modafinil 0 mg + Cocaine (0, 12, 25, and 50mg)	0 of 8 (0%)	0 of 8 (0%)	0 of 8
Modafinil 200 mg + Cocaine (0, 12, 25, and 50mg)	0 of 8 (0%)	0 of 8 (0%)	0 of 8
Modafinil 400 mg + Cocaine (0, 12, 25, and 50mg)	0 of 8 (0%)	0 of 8 (0%)	0 of 8

Limitations and caveats (from the sponsor): This study is limited by the small, non-diverse sample.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Margaret Haney, Ph.D. principal investigator

NYS Psychiatric Institute

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Modafinil 0 mg, Modafinil 200 mg and Modafinil 400 mg in people with Cocaine Dependence, run by New York State Psychiatric Institute 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 5 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 9 Jan 2018. 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 phase mean?

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 9 Jan 2018). 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?

Cocaine Self-administration (time frame: 48 days). 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 NCT01778010.

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 9 Jan 2018.