Trial Outcomes & Findings for Modafinil Treatment for Cocaine-Dependent Individuals (NCT NCT00129285)

NCT ID: NCT00129285

Last Updated: 2018-05-08

Results Overview

Abstinent in the final 3 weeks of treatment

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 210 participants
• Primary outcome timeframe: 3 weeks
• Results posted on: 2018-05-08

Participant Flow

Participant milestones

Measure	Low Dose Modafinil Low Dose Modafinil Modafinil Low Dose: participants received modafinil 200 mg/day	High Dose Modafinil High Dose Modafinil Modafinil High Dose: participants received modafinil 400 mg/day	Placebo Placebo Placebo: participants received placebo 400 mg/day
Overall Study STARTED	65	70	75
Overall Study COMPLETED	40	43	37
Overall Study NOT COMPLETED	25	27	38

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Modafinil Treatment for Cocaine-Dependent Individuals

Baseline characteristics by cohort

Measure	Low Dose Modafinil n=65 Participants Low Dose Modafinil Modafinil Low Dose: modafinil 200 mg/day	High Dose Modafinil n=70 Participants High Dose Modafinil Modafinil High Dose: modafinil 400 mg/day	Placebo n=75 Participants Placebo Placebo: placebo 400 mg/day	Total n=210 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	65 Participants n=5 Participants	70 Participants n=7 Participants	75 Participants n=5 Participants	210 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	41.72 years STANDARD_DEVIATION 6.9 • n=5 Participants	43.64 years STANDARD_DEVIATION 7.7 • n=7 Participants	42.46 years STANDARD_DEVIATION 7.5 • n=5 Participants	42.64 years STANDARD_DEVIATION 8.7 • n=4 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	18 Participants n=7 Participants	19 Participants n=5 Participants	55 Participants n=4 Participants
Sex: Female, Male Male	47 Participants n=5 Participants	52 Participants n=7 Participants	56 Participants n=5 Participants	155 Participants n=4 Participants
Region of Enrollment United States	65 participants n=5 Participants	70 participants n=7 Participants	75 participants n=5 Participants	210 participants n=4 Participants

PRIMARY outcome

Timeframe: 3 weeks

Abstinent in the final 3 weeks of treatment

Outcome measures

Measure	Low Dose Modafinil n=65 Participants Low Dose Modafinil Modafinil Low Dose: participants received modafinil 200 mg/day	High Dose Modafinil n=70 Participants High Dose Modafinil Modafinil High Dose: participants received modafinil 400 mg/day	Placebo n=75 Participants Placebo Placebo: participants received placebo 400 mg/day
Urine Toxicology for Cocaine	3 Participants	8 Participants	3 Participants

SECONDARY outcome

Timeframe: 8 weeks

Number of visits attended compared between the three conditions using anova

Outcome measures

Measure	Low Dose Modafinil n=65 Participants Low Dose Modafinil Modafinil Low Dose: participants received modafinil 200 mg/day	High Dose Modafinil n=70 Participants High Dose Modafinil Modafinil High Dose: participants received modafinil 400 mg/day	Placebo n=75 Participants Placebo Placebo: participants received placebo 400 mg/day
Retention; Number of Evaluation Visits Attended	16.8 number of evaluation sessions attended Standard Deviation 7.1	16.5 number of evaluation sessions attended Standard Deviation 6.7	14.3 number of evaluation sessions attended Standard Deviation 7.1

SECONDARY outcome

Timeframe: 8 weeks

Population: patients exposed to low dose and high dose modafinil

Cocaine Selective Severity assessment (CSSA) total score has a range 0-126. Higher scores indicating greater severity of cocaine withdrawal obtained weekly. Groups compared using GEE model over 8 weeks of treatment.

Outcome measures

Measure	Low Dose Modafinil n=65 Participants Low Dose Modafinil Modafinil Low Dose: participants received modafinil 200 mg/day	High Dose Modafinil n=70 Participants High Dose Modafinil Modafinil High Dose: participants received modafinil 400 mg/day	Placebo n=75 Participants Placebo Placebo: participants received placebo 400 mg/day
Cocaine Selective Severity Assessment (CSSA) Total Score	12.89 units on a scale Standard Deviation 11.70	15.04 units on a scale Standard Deviation 13.52	15.2 units on a scale Standard Deviation 14.32

Adverse Events

Modafinil High Dose

Serious events: 1 serious events

Other events: 63 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 62 other events

Deaths: 0 deaths

Modafinil Low Dose

Serious events: 0 serious events

Other events: 50 other events

Deaths: 0 deaths

Serious adverse events

Measure	Modafinil High Dose n=70 participants at risk Modafinil 400 mg daily	Placebo n=75 participants at risk Placebo daily	Modafinil Low Dose n=65 participants at risk modafinil 200 mg daily
Psychiatric disorders Treatment Emergent Mania	1.4% 1/70 • Number of events 1 • Adverse events were collected over the course of the 8 week trial Adverse events for low and high dose modafinil were combined and compared to adverse events occurring in the placebo comparator group.	0.00% 0/75 • Adverse events were collected over the course of the 8 week trial Adverse events for low and high dose modafinil were combined and compared to adverse events occurring in the placebo comparator group.	0.00% 0/65 • Adverse events were collected over the course of the 8 week trial Adverse events for low and high dose modafinil were combined and compared to adverse events occurring in the placebo comparator group.

Other adverse events

Measure	Modafinil High Dose n=70 participants at risk Modafinil 400 mg daily	Placebo n=75 participants at risk Placebo daily	Modafinil Low Dose n=65 participants at risk modafinil 200 mg daily
General disorders Headache	21.4% 15/70 • Adverse events were collected over the course of the 8 week trial Adverse events for low and high dose modafinil were combined and compared to adverse events occurring in the placebo comparator group.	18.7% 14/75 • Adverse events were collected over the course of the 8 week trial Adverse events for low and high dose modafinil were combined and compared to adverse events occurring in the placebo comparator group.	16.9% 11/65 • Adverse events were collected over the course of the 8 week trial Adverse events for low and high dose modafinil were combined and compared to adverse events occurring in the placebo comparator group.
Musculoskeletal and connective tissue disorders Body Aches	32.9% 23/70 • Adverse events were collected over the course of the 8 week trial Adverse events for low and high dose modafinil were combined and compared to adverse events occurring in the placebo comparator group.	36.0% 27/75 • Adverse events were collected over the course of the 8 week trial Adverse events for low and high dose modafinil were combined and compared to adverse events occurring in the placebo comparator group.	26.2% 17/65 • Adverse events were collected over the course of the 8 week trial Adverse events for low and high dose modafinil were combined and compared to adverse events occurring in the placebo comparator group.
Infections and infestations Upper respiratory tract infection	25.7% 18/70 • Adverse events were collected over the course of the 8 week trial Adverse events for low and high dose modafinil were combined and compared to adverse events occurring in the placebo comparator group.	29.3% 22/75 • Adverse events were collected over the course of the 8 week trial Adverse events for low and high dose modafinil were combined and compared to adverse events occurring in the placebo comparator group.	21.5% 14/65 • Adverse events were collected over the course of the 8 week trial Adverse events for low and high dose modafinil were combined and compared to adverse events occurring in the placebo comparator group.
General disorders Insomnia	12.9% 9/70 • Adverse events were collected over the course of the 8 week trial Adverse events for low and high dose modafinil were combined and compared to adverse events occurring in the placebo comparator group.	6.7% 5/75 • Adverse events were collected over the course of the 8 week trial Adverse events for low and high dose modafinil were combined and compared to adverse events occurring in the placebo comparator group.	9.2% 6/65 • Adverse events were collected over the course of the 8 week trial Adverse events for low and high dose modafinil were combined and compared to adverse events occurring in the placebo comparator group.
General disorders teeth problems	8.6% 6/70 • Adverse events were collected over the course of the 8 week trial Adverse events for low and high dose modafinil were combined and compared to adverse events occurring in the placebo comparator group.	9.3% 7/75 • Adverse events were collected over the course of the 8 week trial Adverse events for low and high dose modafinil were combined and compared to adverse events occurring in the placebo comparator group.	9.2% 6/65 • Adverse events were collected over the course of the 8 week trial Adverse events for low and high dose modafinil were combined and compared to adverse events occurring in the placebo comparator group.
Nervous system disorders Increased energy	14.3% 10/70 • Adverse events were collected over the course of the 8 week trial Adverse events for low and high dose modafinil were combined and compared to adverse events occurring in the placebo comparator group.	2.7% 2/75 • Adverse events were collected over the course of the 8 week trial Adverse events for low and high dose modafinil were combined and compared to adverse events occurring in the placebo comparator group.	9.2% 6/65 • Adverse events were collected over the course of the 8 week trial Adverse events for low and high dose modafinil were combined and compared to adverse events occurring in the placebo comparator group.
Gastrointestinal disorders appetite changes	5.7% 4/70 • Adverse events were collected over the course of the 8 week trial Adverse events for low and high dose modafinil were combined and compared to adverse events occurring in the placebo comparator group.	10.7% 8/75 • Adverse events were collected over the course of the 8 week trial Adverse events for low and high dose modafinil were combined and compared to adverse events occurring in the placebo comparator group.	9.2% 6/65 • Adverse events were collected over the course of the 8 week trial Adverse events for low and high dose modafinil were combined and compared to adverse events occurring in the placebo comparator group.
Gastrointestinal disorders Nausea	5.7% 4/70 • Adverse events were collected over the course of the 8 week trial Adverse events for low and high dose modafinil were combined and compared to adverse events occurring in the placebo comparator group.	5.3% 4/75 • Adverse events were collected over the course of the 8 week trial Adverse events for low and high dose modafinil were combined and compared to adverse events occurring in the placebo comparator group.	7.7% 5/65 • Adverse events were collected over the course of the 8 week trial Adverse events for low and high dose modafinil were combined and compared to adverse events occurring in the placebo comparator group.
Gastrointestinal disorders Diarrhea	8.6% 6/70 • Adverse events were collected over the course of the 8 week trial Adverse events for low and high dose modafinil were combined and compared to adverse events occurring in the placebo comparator group.	5.3% 4/75 • Adverse events were collected over the course of the 8 week trial Adverse events for low and high dose modafinil were combined and compared to adverse events occurring in the placebo comparator group.	3.1% 2/65 • Adverse events were collected over the course of the 8 week trial Adverse events for low and high dose modafinil were combined and compared to adverse events occurring in the placebo comparator group.
Gastrointestinal disorders Stomach problems	8.6% 6/70 • Adverse events were collected over the course of the 8 week trial Adverse events for low and high dose modafinil were combined and compared to adverse events occurring in the placebo comparator group.	5.3% 4/75 • Adverse events were collected over the course of the 8 week trial Adverse events for low and high dose modafinil were combined and compared to adverse events occurring in the placebo comparator group.	3.1% 2/65 • Adverse events were collected over the course of the 8 week trial Adverse events for low and high dose modafinil were combined and compared to adverse events occurring in the placebo comparator group.
General disorders Dry mouth	4.3% 3/70 • Adverse events were collected over the course of the 8 week trial Adverse events for low and high dose modafinil were combined and compared to adverse events occurring in the placebo comparator group.	4.0% 3/75 • Adverse events were collected over the course of the 8 week trial Adverse events for low and high dose modafinil were combined and compared to adverse events occurring in the placebo comparator group.	7.7% 5/65 • Adverse events were collected over the course of the 8 week trial Adverse events for low and high dose modafinil were combined and compared to adverse events occurring in the placebo comparator group.
General disorders Fatigue	5.7% 4/70 • Adverse events were collected over the course of the 8 week trial Adverse events for low and high dose modafinil were combined and compared to adverse events occurring in the placebo comparator group.	5.3% 4/75 • Adverse events were collected over the course of the 8 week trial Adverse events for low and high dose modafinil were combined and compared to adverse events occurring in the placebo comparator group.	4.6% 3/65 • Adverse events were collected over the course of the 8 week trial Adverse events for low and high dose modafinil were combined and compared to adverse events occurring in the placebo comparator group.

Additional Information

Kyle Kampman

University of Pennsylvania Treatment Research Center

Phone: 215-746-2764

Email: kampman@mail.med.upenn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place