Trial Outcomes & Findings for Modafinil Treatment for Cocaine Dependence and HIV High-Risk Behavior (NCT NCT00368290)

NCT ID: NCT00368290

Last Updated: 2018-03-15

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 94 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2018-03-15

Participant Flow

Participant milestones

Measure	Modafinil 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 placebo plus CBT placebo: placebo pills for 8 weeks Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks.
Overall Study STARTED	47	47
Overall Study COMPLETED	34	37
Overall Study NOT COMPLETED	13	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Modafinil Treatment for Cocaine Dependence and HIV High-Risk Behavior

Baseline characteristics by cohort

Measure	Modafinil n=47 Participants 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 n=47 Participants 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 n=94 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
Age, Categorical Between 18 and 65 years	47 Participants n=5 Participants	47 Participants n=7 Participants	94 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants	39 Participants n=7 Participants	77 Participants n=5 Participants
Region of Enrollment United States	47 participants n=5 Participants	47 participants n=7 Participants	94 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

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

Outcome measures

Measure	Modafinil n=47 Participants 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 n=47 Participants placebo plus CBT placebo: placebo pills for 8 weeks Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks.
Percent of Participants Reporting no Cocaine Craving	64 Percent of participants	41 Percent of participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Modafinil n=47 Participants 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 n=47 Participants placebo plus CBT placebo: placebo pills for 8 weeks Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks.
Cocaine Use as Measured by Urine Drug Screen	23 Percentage of Participants	9 Percentage of Participants

Adverse Events

Modafinil

Serious events: 6 serious events

Other events: 23 other events

Deaths: 0 deaths

Placebo

Serious events: 9 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Measure	Modafinil n=47 participants at risk 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 n=47 participants at risk placebo plus CBT placebo: placebo pills for 8 weeks Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks.
General disorders Loss of Conciousness	2.1% 1/47 • Number of events 1	0.00% 0/47
General disorders Exacerbation of Cocaine Dependence	6.4% 3/47 • Number of events 4	10.6% 5/47 • Number of events 5
Psychiatric disorders Hospitalization for Depression	2.1% 1/47 • Number of events 1	4.3% 2/47 • Number of events 2
Respiratory, thoracic and mediastinal disorders Hospitalization for Asthama	2.1% 1/47 • Number of events 2	0.00% 0/47
Eye disorders Hospitalization for eye injury	0.00% 0/47	2.1% 1/47 • Number of events 1
Infections and infestations Infection in laceration on right hand	0.00% 0/47	2.1% 1/47 • Number of events 1

Other adverse events

Measure	Modafinil n=47 participants at risk 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 n=47 participants at risk placebo plus CBT placebo: placebo pills for 8 weeks Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks.
General disorders Headache	12.8% 6/47	14.9% 7/47
General disorders Insomnia	21.3% 10/47	6.4% 3/47
Psychiatric disorders Anxiety	14.9% 7/47	4.3% 2/47

Additional Information

Dr. Kyle Kampman

University of Pennsylvania

Phone: 215-222-3200

Email: kampman@mail.med.upenn.edu

Results disclosure agreements

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