Modafinil, Sleep Architecture and Cocaine Relapse

• Sponsor: Yale University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01137396
• Collaborator: (none)
• Enrollment: 114
• Location: 1
• Arms: 2
• Duration (Months): 58.1
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief Summary

The medication modafinil has been shown to reduce cocaine use in some cocaine users. The investigators have shown that modafinil taken in the morning improves sleep in chronic cocaine users. The investigators hypothesize that the beneficial effects of modafinil in reducing cocaine use may be related to specific effects modafinil has on sleep. This study will measure sleep and cocaine use in cocaine dependent persons who are trying to stop using cocaine, and will test the connection between modafinil's effects on sleep and cocaine use.

Condition or Disease	Intervention/Treatment	Phase
Cocaine Dependence	Drug: Modafinil; Behavioral: Cognitive Behavioral Therapy	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 114 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Modafinil, Sleep Architecture and Cocaine Relapse
• Study Start Date: Apr 1, 2010
• Actual Primary Completion Date: Feb 1, 2015
• Actual Study Completion Date: Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Modafinil	Drug: Modafinil; Modafinil 400mg PO QDaily following up-titration for ~8weeks; Behavioral: Cognitive Behavioral Therapy; Once weekly cognitive behavioral therapy for cocaine dependence
Placebo Comparator: Placebo	Behavioral: Cognitive Behavioral Therapy; Once weekly cognitive behavioral therapy for cocaine dependence

Outcome Measures

Primary Outcome Measures

1. %Cocaine Free Urines [3x/week]

Secondary Outcome Measures

1. Change in N3 (Slow-wave) Sleep Time [change from week 1 to week 2 of inpatient treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 25-50 years of age;

• voluntary, written, informed consent;

• seeking but not currently enrolled in treatment for cocaine use;

• self-reported, current use of cocaine by smoked or intravenous route at least one time each week in the past month, with ≥1g used within a single 24-hour period and ≥3g used in the month;

• positive urine test for cocaine (benzoylecognine) at the time of screening and study start

• dependence on cocaine in the past year as measured by a score ≥ 3 on the Severity of Dependence Scale(Kaye and Darke, 2002);

• chronic use in the past year as determined by self-reported use in at least 9 of the past 12 months;

• lifetime diagnosis of cocaine dependence with a duration of at least 2 years as determined by the Structured Clinical Interview for DSM-IV (SCID).

Exclusion Criteria:

• evidence of any neurological condition or a chronic medical condition including diabetes, cardiovascular disease or history of cardiac problems, HIV-seropositivity, liver disease, hypertension, asthma requiring daily medication, dementia, movement disorder, history of head trauma with loss of consciousness, sleep apnea, narcolepsy, restless leg syndrome, periodic limb movement disorder, REM sleep disorder, pharmacological treatment for insomnia of any type within the past 6 months, glaucoma, severe respiratory insufficiency, seizure disorder, or if in the past three months they have taken any medications that affect sleep, or are currently taking any regularly dosed prescription medication or any prn medication that is used on average more than 1x/week

• evidence of chronic sleep disorder including sleep apnea, narcolepsy, periodic limb movement disorder, restless leg syndrome as determined by medical history, Sleep Disorders Questionnaire(Douglass, 1994), or by polysomnography (following enrollment)

• current dependence on any drugs other than cocaine or nicotine or lifetime dependence on alcohol, benzodiazepines, or opiates, or any non-substance related Axis I disorder as determined by SCID

• current use of alcohol in excess of 3x/week AND 21 standard drinks/week in the past month or non-zero breathalyzer at screening or study start

• current use of cannabis in the past month

• positive urine toxicology test for opiates, methadone, amphetamines, barbiturates, benzodiazepines, PCP, methaquolone, and propoxyphene at the time of screening or positive test for any of those listed plus cannabis at the time of study start

• pregnancy as determined by serum β-HCG at screening or lactating per report

• females: unwillingness to use barrier contraceptives during sexual intercourse for the duration of the study

• known hypersensitivity to modafinil.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Connecticut Mental Health Center	New Haven	Connecticut	United States	06519

Sponsors and Collaborators

• Yale University

Investigators

• Principal Investigator: Peter Morgan, MD, PhD, Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT01137396
• Other Study ID Numbers: 0911005989; DA011744-08
• First Posted: Jun 4, 2010
• Last Update Posted: Apr 27, 2016
• Last Verified: Mar 1, 2016

• Additional relevant MeSH terms: Cocaine-Related Disorders; Modafinil

Study Results

Participant Flow

Arm/Group Title	Modafinil	Placebo
Arm/Group Description	Modafinil: Modafinil 400mg PO QDaily following up-titration for ~8weeks Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence	Placebo: Placebo medication Qdaily for ~8weeks Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence
Period Title: Overall Study
STARTED	30	27
COMPLETED	22	25
NOT COMPLETED	8	2

Baseline Characteristics

Arm/Group Title	Modafinil	Placebo	Total
Arm/Group Description	Modafinil: Modafinil 400mg PO QDaily following up-titration for ~8weeks Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence	Placebo: Placebo medication Qdaily for ~8weeks Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence	Total of all reporting groups
Overall Participants	30	27	57
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	42 (7)	44 (7)	43 (7)
Sex: Female, Male (Count of Participants)
Female	7 23.3%	6 22.2%	13 22.8%
Male	23 76.7%	21 77.8%	44 77.2%

Outcome Measures

1. Primary Outcome

Title	%Cocaine Free Urines
Time Frame	3x/week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Modafinil	Placebo
Arm/Group Description	Modafinil: Modafinil 400mg PO QDaily following up-titration for ~8weeks Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence	Placebo: Placebo medication Qdaily for ~8weeks Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence
Measure Participants	22	25
Mean (Standard Error) [percent]	52 (9)	26 (7)

2. Secondary Outcome

Title	Change in N3 (Slow-wave) Sleep Time
Time Frame	change from week 1 to week 2 of inpatient treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Modafinil	Placebo
Arm/Group Description	Modafinil: Modafinil 400mg PO QDaily following up-titration for ~8weeks Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence	Placebo: Placebo medication Qdaily for ~8weeks Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence
Measure Participants	22	25
Mean (Standard Error) [minutes]	16 (4)	-2.5 (4)

Adverse Events

Arm/Group Title	Modafinil		Placebo
Arm/Group Description	Modafinil: Modafinil 400mg PO QDaily following up-titration for ~8weeks Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence		Placebo: Placebo medication Qdaily for ~8weeks Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence
All Cause Mortality
	Modafinil		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Modafinil		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/27 (0%)
Other (Not Including Serious) Adverse Events
	Modafinil		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/27 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.