MOD6: Modafinil Treatment for Cocaine Dependence and HIV High-Risk Behavior

• Sponsor: Kyle Kampman (Other)
• Overall Status: Completed
• CT.gov ID: NCT00368290
• Collaborator: (none)
• Enrollment: 94
• Arms: 2
• Duration (Months): 76

Study Details

Study Description

Brief Summary

The purpose of study is to determine if modafinil promotes cocaine abstinence and reduces high risk behavior in cocaine dependent subjects.

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

Detailed Description

The purpose of study is to determine if modafinil promotes cocaine abstinence and reduces HRB in cocaine dependent subjects. Modafinil (300 mg/day) or placebo will be administered in an 8-week double-blind trial to patients meeting diagnostic criteria for cocaine dependence in conjunction with Cognitive Behavioral Therapy (CBT).

Study Design

• Study Type: Interventional
• Actual Enrollment: 94 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Modafinil Treatment for Cocaine Dependence and HIV-High Risk Behavior
• Study Start Date: Sep 1, 2006
• Actual Primary Completion Date: Jan 1, 2013
• Actual Study Completion Date: Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 modafinil plus CBT	Drug: Modafinil; 300mg a day for 8 weeks; Other Names: Provigil ; Behavioral: Cognitive Behavioral Therapy (CBT); Weekly cognitive behavioral therapy sessions for a period of 8 weeks.
Placebo Comparator: 2 placebo plus CBT	Drug: placebo; placebo pills for 8 weeks; Behavioral: Cognitive Behavioral Therapy (CBT); Weekly cognitive behavioral therapy sessions for a period of 8 weeks.

Outcome Measures

Primary Outcome Measures

1. Percent of Participants Reporting no Cocaine Craving [8 weeks]

   Percent of participants reporting no cocaine craving based on Brief Substance Craving Scale (BSCS) - a 4 point likert scale.

2. Cocaine Use as Measured by Urine Drug Screen [8 weeks]

   The primary outcome measure was cocaine use measured by self-report, and confirmed by twice weekly urine drug screens. The percentage of participants shows the percentage who were abstinent from cocaine during the last 3 weeks of the trial.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. 18 - 60 years;

2. Current DSM-IV diagnosis of cocaine dependence;

3. Using cocaine at least 8 days in a consecutive 30 day period over the 60 day period immediately preceding study entry (If subject was receiving inpatient substance abuse treatment within 30 days prior to screening, subject must have been using cocaine at least 8 days in a consecutive 30 day period over the 60 day period immediately preceding admission to inpatient treatment); 4.)Having a negative urine toxicology (BE) test during screening (no less than 5 days prior to randomization) and a negative urine toxicology (BE) test on the day of randomization. Repeat testing allowed until required negative BE results are obtained;

4. Able to provide written informed consent and to comply with all study procedures;

5. Women must be surgically sterile, at least two years postmenopausal, or, if of childbearing potential, be using a medically accepted method of birth control and agree to continue use of this method for at least 30 days after the last dose of study drug (i.e. barrier method with spermicide, steroidal contraceptive [oral and implanted, including Depo-Provera, contraceptives must be used in conjunction with a barrier method], or intrauterine device [IUD]).

Exclusion Criteria:

1. Currently dependent on any substance other than cocaine or nicotine;

2. Current Neurological or psychiatric disorders, such as psychosis, bipolar illness, organic brain disease, dementia, or any diseases that require psychotropic medications;

3. Serious medical illnesses, including but not limited to; uncontrolled hypertension, significant heart disease (including a history of myocardial infarction, angina, mitral valve prolapse, left ventricular hypertrophy, palpitations, and arrhythmia), hepatic disease, renal disease, or any serious, potentially life-threatening or progressive medical illness that may compromise patient safety or study conduct;

4. Received a drug with known potential for toxicity to a major organ system within the month prior to entering treatment including, but not limited to: chemotherapeutic agents for neoplastic disease (i.e. methotrexate, vincristine, vinblastine, fluorouracil), agents used for parasitic infections, isoniazid, chlorambucil, dactinomycin, chloramphenicol, immunosuppressive and cytotoxic agents (i.e. cyclosporine, tacrolimus), indomethacin, protease inhibitors, amphotericin B, cephalosporins, aminoglycosides, interferon, and sulfonamides;

5. Clinically significant abnormal laboratory values (see Appendix A);

6. Has any disease of the gastrointestinal system, liver, or kidneys which could result in altered metabolism or excretion of the study medication (history of major gastrointestinal tract surgery, gastrectomy, gastrostomy, bowel resection, etc.) or history of chronic gastrointestinal disorders (ulcerative colitis, regional enteritis, or gastrointestinal bleeding);

7. Known hypersensitivity or allergy to modafinil, or receiving chronic therapy with any medication that could interact adversely with modafinil, including propranolol, phenytoin, warfarin and diazepam;

8. Took monoamine oxidase inhibitors (MAOI) within 30 days prior to randomization;

9. Taking or has taken an investigational drug within 60 days prior to randomization;

10. If female and of child-bearing capacity, tests positive on a urine pregnancy test, is lactating, has had three or more days of amenorrhea beyond expected menses at the time of the first dose of study medication, is contemplating pregnancy in the next 6 months, or is not using an effective contraceptive method;

11. Received therapy with any opiate-substitute (methadone, LAAM, buprenorphine) within 60 days of study enrollment.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Kyle Kampman

Investigators

• Principal Investigator: Kyle M Kampman, M.D., University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kyle Kampman, Sponsor-Investigator, University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT00368290
• Other Study ID Numbers: 804537
• First Posted: Aug 24, 2006
• Last Update Posted: Mar 15, 2018
• Last Verified: Feb 1, 2018

• Keywords provided by Kyle Kampman, Sponsor-Investigator, University of Pennsylvania: cocaine dependence; hiv prevention
• Additional relevant MeSH terms: Cocaine-Related Disorders; Modafinil

Study Results

Participant Flow

Arm/Group Title	Modafinil	Placebo
Arm/Group Description	modafinil plus CBT Modafinil: 300mg a day for 8 weeks Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks.	placebo plus CBT placebo: placebo pills for 8 weeks Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks.
Period Title: Overall Study
STARTED	47	47
COMPLETED	34	37
NOT COMPLETED	13	10

Baseline Characteristics

Arm/Group Title	Modafinil	Placebo	Total
Arm/Group Description	modafinil plus CBT Modafinil: 300mg a day for 8 weeks Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks.	placebo plus CBT placebo: placebo pills for 8 weeks Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks.	Total of all reporting groups
Overall Participants	47	47	94
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	47 100%	47 100%	94 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	9 19.1%	8 17%	17 18.1%
Male	38 80.9%	39 83%	77 81.9%
Region of Enrollment (participants) [Number]
United States	47 100%	47 100%	94 100%

Outcome Measures

1. Primary Outcome

Title	Percent of Participants Reporting no Cocaine Craving
Description	Percent of participants reporting no cocaine craving based on Brief Substance Craving Scale (BSCS) - a 4 point likert scale.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Modafinil	Placebo
Arm/Group Description	modafinil plus CBT Modafinil: 300mg a day for 8 weeks Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks.	placebo plus CBT placebo: placebo pills for 8 weeks Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks.
Measure Participants	47	47
Number [Percent of participants]	64 136.2%	41 87.2%

2. Primary Outcome

Title	Cocaine Use as Measured by Urine Drug Screen
Description	The primary outcome measure was cocaine use measured by self-report, and confirmed by twice weekly urine drug screens. The percentage of participants shows the percentage who were abstinent from cocaine during the last 3 weeks of the trial.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Modafinil	Placebo
Arm/Group Description	modafinil plus CBT Modafinil: 300mg a day for 8 weeks Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks.	placebo plus CBT placebo: placebo pills for 8 weeks Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks.
Measure Participants	47	47
Number [Percentage of Participants]	23 48.9%	9 19.1%

Adverse Events

Arm/Group Title	Modafinil		Placebo
Arm/Group Description	modafinil plus CBT Modafinil: 300mg a day for 8 weeks Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks.		placebo plus CBT placebo: placebo pills for 8 weeks Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks.
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	6/47 (12.8%)		9/47 (19.1%)
Eye disorders
Hospitalization for eye injury	0/47 (0%)	0	1/47 (2.1%)	1
General disorders
Loss of Conciousness	1/47 (2.1%)	1	0/47 (0%)	0
Exacerbation of Cocaine Dependence	3/47 (6.4%)	4	5/47 (10.6%)	5
Infections and infestations
Infection in laceration on right hand	0/47 (0%)	0	1/47 (2.1%)	1
Psychiatric disorders
Hospitalization for Depression	1/47 (2.1%)	1	2/47 (4.3%)	2
Respiratory, thoracic and mediastinal disorders
Hospitalization for Asthama	1/47 (2.1%)	2	0/47 (0%)	0
Other (Not Including Serious) Adverse Events
	Modafinil		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	23/47 (48.9%)		12/47 (25.5%)
General disorders
Headache	6/47 (12.8%)		7/47 (14.9%)
Insomnia	10/47 (21.3%)		3/47 (6.4%)
Psychiatric disorders
Anxiety	7/47 (14.9%)		2/47 (4.3%)

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.