Modafinil Combined With Cognitive Behavior Therapy to Treat Cocaine Addiction - 1

• Sponsor: Medical University of South Carolina (Other)
• Overall Status: Completed
• CT.gov ID: NCT00218387
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 123
• Location: 1
• Arms: 3
• Duration (Months): 75
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

Cocaine addiction is a serious health problem with no available medical treatment for preventing relapse. Modafinil, a medication that enhances mood, increases energy, and improves concentration, may be useful in preventing relapse among individuals with cocaine addiction. This study will evaluate the effectiveness of modafinil, in combination with cognitive behavior therapy (CBT), to prevent drug relapse among cocaine addicts.

Condition or Disease	Intervention/Treatment	Phase
Cocaine Dependence	Drug: Modafinil; Drug: Modafinil; Drug: Matching Placebo	Phase 2

Detailed Description

The development of a medication to treat cocaine addiction specifically by lessening withdrawal symptoms has been a primary focus of research. Common cocaine withdrawal symptoms include depression, lack of energy, and poor concentration. Modafinil, a central nervous system stimulant, is a medication that can speed up physical and mental processes in the brain. It is currently used to treat narcolepsy, a condition that causes excessive sleepiness. Modafinil enhances mood, increases energy, and improves concentration in people with narcolepsy. Modafinil may also cause the same effects in individuals addicted to cocaine, thereby countering the symptoms of cocaine withdrawal. The purpose of this study is to compare the effectiveness of modafinil plus CBT versus placebo plus CBT for treating cocaine dependence.

A 2-week screening period will be followed by an 8-week treatment phase. Participants will be randomly assigned to receive either 200 mg of modafinil, 400 mg of modafinil, or placebo on a daily basis for the 8 weeks of treatment. During this time, participants will be asked to report the number of days that they use and do not use cocaine. This will be confirmed three times a week with urine tests. Mood, level of daytime sleepiness, and symptoms of cocaine withdrawal and cocaine "high" will be evaluated. Compliance with study medication will be assessed with urine and blood tests. Medication side effects will be monitored through physical examinations, routine lab tests, ECGs, and self-reports. Follow-up evaluations will occur 4 and 8 weeks following the end of treatment.

Study Design

• Study Type: Interventional
• Actual Enrollment: 123 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: CBT and Modafinil for Cocaine Addiction
• Study Start Date: Apr 1, 2004
• Actual Primary Completion Date: Jul 1, 2010
• Actual Study Completion Date: Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 200mg Modafinil 200mg Modafinil	Drug: Modafinil; 200mg Modafinil; Other Names: Provigil
Experimental: 400mg Modafinil 400mg Modafinil	Drug: Modafinil; 400mg Modafinil; Other Names: Provigil
Placebo Comparator: Matching Placebo Matching Placebo	Drug: Matching Placebo; Matching Placebo

Outcome Measures

Primary Outcome Measures

1. Number of Cocaine Non-use Days [8 weeks]

   Number of cocaine non-use days was determined by Urine Drug Screen tests which confirmed presence (or no presence) of benzoylecgonine levels.

2. Percent of Participants With New Use [8 weeks]

   New Use is defined as a period of at least 7 days abstinence followed by a positive urine drug screen.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Seeking treatment for cocaine dependence

• Meets DSM-IV diagnosis criteria for cocaine dependence as determined by Mini-SCID interview

• If female, willing to use effective contraception throughout the study

• Lives within 50 miles of the research center and has reliable transportation

Exclusion criteria:

• Meets DSM-IV/Mini-SCID diagnosis criteria for dependence on any drugs other than cocaine, alcohol, nicotine, or marijuana

• Physiologic dependence on alcohol requiring medical detoxification, on either an inpatient or outpatient basis

• Current psychiatric disorder, including depression, schizophrenia, bipolar affective disorder, organic brain disease, dementia, or other types of psychosis

• Recent suicidal or homicidal attempts within 60 days of study entry

• Suicidal or homicidal ideation within 30 days of study entry

• Meets diagnosis criteria from the Differential Diagnosis of Psychotic Disorders section of Mini-SCID for a history of psychotic symptoms during a period of cocaine use (e.g., persistent hallucinations and delusions)

• Serious medical illness, including left ventricular hypertrophy, mitral valve prolapse, left bundle branch block, heart attack, angina, serious liver disease (transaminase levels four times greater than normal), and kidney, neurologic, metabolic, neoplastic, nutritional, inflammatory, or endocrine disorders

• Required by the court to obtain treatment for cocaine dependence

• Not seeking treatment for cocaine dependence

• Participated in cocaine treatment (clinical or research) within 30 days of study entry

• Anticipating elective surgery or hospitalization within 20 weeks of study entry

• Known or suspected hypersensitivity to modafinil

• Use of any of the following medications within 14 days of study entry: selective serotonin reuptake inhibitor antidepressants, tricyclic antidepressants, dopamine agonists, and other psychotropic medications, including anticonvulsants, antipsychotics, anxiolytics, or psychostimulants

• Currently taking medications that could adversely interact with study medications, including azole-type antifungals, cyclosporine, warfarin, theophylline, or carbamazepine

• Currently taking any medications that induce or inhibit CYP3A4 metabolic pathways

• Pregnant or breastfeeding

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of South Carolina	Charleston	South Carolina	United States	29425

Sponsors and Collaborators

• Medical University of South Carolina
• National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Robert Malcolm, MD, Medical University of South Carolina

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Robert Malcolm, Professor of Psychiatry, Family Medicine & Pediatrics, Medical University of South Carolina
• ClinicalTrials.gov Identifier: NCT00218387
• Other Study ID Numbers: NIDA-16368-1; R01DA016368; R01-16368-1; DPMC
• First Posted: Sep 22, 2005
• Last Update Posted: Apr 10, 2019
• Last Verified: Mar 1, 2019

• Keywords provided by Robert Malcolm, Professor of Psychiatry, Family Medicine & Pediatrics, Medical University of South Carolina: Cocaine Dependence
• Additional relevant MeSH terms: Cocaine-Related Disorders; Modafinil

Study Results

Participant Flow

Arm/Group Title	200mg Modafinil	400mg Modafinil	Matching Placebo
Arm/Group Description	200mg Modafinil Modafinil: 200mg Modafinil	400mg Modafinil Modafinil: 400mg Modafinil	Matching Placebo Matching Placebo: Matching Placebo
Period Title: Overall Study
STARTED	40	43	40
COMPLETED	25	25	17
NOT COMPLETED	15	18	23

Baseline Characteristics

Arm/Group Title	200mg Modafinil	400mg Modafinil	Matching Placebo	Total
Arm/Group Description	200mg Modafinil Modafinil: 200mg Modafinil	400mg Modafinil Modafinil: 400mg Modafinil	Matching Placebo Matching Placebo: Matching Placebo	Total of all reporting groups
Overall Participants	40	43	40	123
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	39.0 (7.1)	40.4 (7.2)	40.0 (8.8)	39.8 (7.2)
Sex: Female, Male (Count of Participants)
Female	10 25%	10 23.3%	9 22.5%	29 23.6%
Male	30 75%	33 76.7%	31 77.5%	94 76.4%

Outcome Measures

1. Primary Outcome

Title	Number of Cocaine Non-use Days
Description	Number of cocaine non-use days was determined by Urine Drug Screen tests which confirmed presence (or no presence) of benzoylecgonine levels.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

The amount of subjects represent those that completed 8 weeks of treatment. The exclusion of alcohol dependence listed in the exclusion criteria within the protocol is referring to a physiological dependence on alcohol requiring a medical detox.

Arm/Group Title	200mg Modafinil	400mg Modafinil	Matching Placebo
Arm/Group Description	200mg Modafinil Modafinil: 200mg Modafinil	400mg Modafinil Modafinil: 400mg Modafinil	Matching Placebo Matching Placebo: Matching Placebo
Measure Participants	25	25	17
No Alcohol Dependence	10.1 (2.4)	17.1 (2.3)	9.3 (2.7)
Alcohol Dependence	14.1 (2.5)	9.4 (2.5)	12.8 (2.4)

2. Primary Outcome

Title	Percent of Participants With New Use
Description	New Use is defined as a period of at least 7 days abstinence followed by a positive urine drug screen.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

The amount of subjects represent those that completed 8 weeks of treatment. The exclusion of alcohol dependence listed in the exclusion criteria within the protocol is referring to a physiological dependence on alcohol requiring a medical detox.

Arm/Group Title	200mg Modafinil	400mg Modafinil	Matching Placebo
Arm/Group Description	200mg Modafinil Modafinil: 200mg Modafinil	400mg Modafinil Modafinil: 400mg Modafinil	Matching Placebo Matching Placebo: Matching Placebo
Measure Participants	25	25	17
No Alcohol Dependence	54.2 135.5%	42.0 97.7%	55.8 139.5%
Alcohol Dependence	39.7 99.3%	42.0 97.7%	49.0 122.5%

Adverse Events

Arm/Group Title	200mg Modafinil		400mg Modafinil		Matching Placebo
Arm/Group Description	200mg Modafinil Modafinil: 200mg Modafinil		400mg Modafinil Modafinil: 400mg Modafinil		Matching Placebo Matching Placebo: Matching Placebo
All Cause Mortality
	200mg Modafinil		400mg Modafinil		Matching Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	200mg Modafinil		400mg Modafinil		Matching Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/43 (0%)		0/40 (0%)
Other (Not Including Serious) Adverse Events
	200mg Modafinil		400mg Modafinil		Matching Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	33/40 (82.5%)		34/43 (79.1%)		27/40 (67.5%)
Cardiac disorders
Heart Racing	5/40 (12.5%)	5	5/43 (11.6%)	6	1/40 (2.5%)	1
Rapid Heart Rate	3/40 (7.5%)	3	3/43 (7%)	3	0/40 (0%)	0
Chest Pain	2/40 (5%)	2	0/43 (0%)	0	1/40 (2.5%)	1
Gastrointestinal disorders
Nausea	5/40 (12.5%)	5	8/43 (18.6%)	8	5/40 (12.5%)	5
Dry Mouth	1/40 (2.5%)	1	3/43 (7%)	3	0/40 (0%)	0
Heartburn	1/40 (2.5%)	1	2/43 (4.7%)	2	3/40 (7.5%)	3
Infections and infestations
Upper Respiratory Infection	2/40 (5%)	2	2/43 (4.7%)	2	0/40 (0%)	0
Musculoskeletal and connective tissue disorders
Muscle Ache	4/40 (10%)	4	1/43 (2.3%)	1	1/40 (2.5%)	1
Nervous system disorders
Numbness	1/40 (2.5%)	1	2/43 (4.7%)	3	1/40 (2.5%)	1
Headache	13/40 (32.5%)	17	16/43 (37.2%)	17	10/40 (25%)	11
Psychiatric disorders
Irritability	0/40 (0%)	0	0/43 (0%)	0	2/40 (5%)	2
Insomnia	7/40 (17.5%)	7	12/43 (27.9%)	12	3/40 (7.5%)	3
Sleepiness	1/40 (2.5%)	1	2/43 (4.7%)	3	6/40 (15%)	6
Jitteriness	2/40 (5%)	3	0/43 (0%)	0	0/40 (0%)	0
Skin and subcutaneous tissue disorders
Toothache	1/40 (2.5%)	1	0/43 (0%)	0	2/40 (5%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.