Trial Outcomes & Findings for Modafinil and Naltrexone to Reduce Cocaine and Alcohol Dependence (NCT NCT00142818)

NCT ID: NCT00142818

Last Updated: 2020-07-16

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 164 participants
• Primary outcome timeframe: 13 weeks
• Results posted on: 2020-07-16

Participant Flow

Participant milestones

Measure	ModNal Nal + Mod Naltrexone: 150 mg daily for males; 100 mg daily for females Modafinil: 400 mg daily	Naltrexone and Placebo Nal Naltrexone: 150 mg daily for males; 100 mg daily for females	Modafinil and Placebo Mod Modafinil: 400 mg daily	Double Placebo Placebo Placebo: 400 mg and/or 100-150 mg placebo pills
Overall Study STARTED	45	40	37	42
Overall Study COMPLETED	28	19	24	20
Overall Study NOT COMPLETED	17	21	13	22

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Modafinil and Naltrexone to Reduce Cocaine and Alcohol Dependence

Baseline characteristics by cohort

Measure	ModNal n=45 Participants Nal + Mod Naltrexone: 150 mg daily for males; 100 mg daily for females Modafinil: 400 mg daily	Naltrexone and Placebo n=40 Participants Nal Naltrexone: 150 mg daily for males; 100 mg daily for females	Modafinil and Placebo n=37 Participants Mod Modafinil: 400 mg daily	Double Placebo n=42 Participants Placebo Placebo: 400 mg and/or 100-150 mg placebo pills	Total n=164 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	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	45 Participants n=5 Participants	40 Participants n=7 Participants	37 Participants n=5 Participants	42 Participants n=4 Participants	164 Participants n=21 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	0 Participants n=21 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants	14 Participants n=4 Participants	41 Participants n=21 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	35 Participants n=7 Participants	30 Participants n=5 Participants	28 Participants n=4 Participants	123 Participants n=21 Participants
Region of Enrollment United States	45 participants n=5 Participants	40 participants n=7 Participants	37 participants n=5 Participants	42 participants n=4 Participants	164 participants n=21 Participants

PRIMARY outcome

Timeframe: 13 weeks

Outcome measures

Measure	ModNal n=45 Participants Nal + Mod Naltrexone: 150 mg daily for males; 100 mg daily for females Modafinil: 400 mg daily	Naltrexone and Placebo n=40 Participants Nal Naltrexone: 150 mg daily for males; 100 mg daily for females	Modafinil and Placebo n=37 Participants Mod Modafinil: 400 mg daily	Double Placebo n=42 Participants Placebo Placebo: 400 mg and/or 100-150 mg placebo pills
Cocaine Use (Measured by Timeline Follow Back and Urine Screen From Week 2-week 14)	9.3 number of cocaine negative urine samples Standard Deviation 8.4	7.2 number of cocaine negative urine samples Standard Deviation 8.1	10.1 number of cocaine negative urine samples Standard Deviation 9.4	10.5 number of cocaine negative urine samples Standard Deviation 9.9

PRIMARY outcome

Timeframe: 13 weeks

Outcome measures

Measure	ModNal n=45 Participants Nal + Mod Naltrexone: 150 mg daily for males; 100 mg daily for females Modafinil: 400 mg daily	Naltrexone and Placebo n=40 Participants Nal Naltrexone: 150 mg daily for males; 100 mg daily for females	Modafinil and Placebo n=37 Participants Mod Modafinil: 400 mg daily	Double Placebo n=42 Participants Placebo Placebo: 400 mg and/or 100-150 mg placebo pills
Percent Days of Heavy Drinking (Measured by Timeline Follow Back Starting at Week Two Through Week 14	34.7 mean percentage of days Standard Error 4.4	35.1 mean percentage of days Standard Error 4.2	33.6 mean percentage of days Standard Error 4.2	33.8 mean percentage of days Standard Error 4.3

Adverse Events

ModNal

Serious events: 11 serious events

Other events: 11 other events

Deaths: 0 deaths

Naltrexone and Placebo

Serious events: 6 serious events

Other events: 10 other events

Deaths: 0 deaths

Modafinil and Placebo

Serious events: 6 serious events

Other events: 8 other events

Deaths: 0 deaths

Double Placebo

Serious events: 11 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	ModNal n=45 participants at risk Nal + Mod Naltrexone: 150 mg daily for males; 100 mg daily for females Modafinil: 400 mg daily	Naltrexone and Placebo n=40 participants at risk Nal Naltrexone: 150 mg daily for males; 100 mg daily for females	Modafinil and Placebo n=37 participants at risk Mod Modafinil: 400 mg daily	Double Placebo n=42 participants at risk Placebo Placebo: 400 mg and/or 100-150 mg placebo pills
General disorders Hospitalization	15.6% 7/45 • Number of events 9	7.5% 3/40 • Number of events 3	8.1% 3/37 • Number of events 3	16.7% 7/42 • Number of events 11
General disorders Exacerbation of cocaine and alcohol	8.9% 4/45 • Number of events 4	5.0% 2/40 • Number of events 2	8.1% 3/37 • Number of events 3	14.3% 6/42 • Number of events 6
Psychiatric disorders Depression or Hallucinations	2.2% 1/45 • Number of events 1	0.00% 0/40	0.00% 0/37	2.4% 1/42 • Number of events 1
Social circumstances Arrested for Homicide	0.00% 0/45	2.5% 1/40 • Number of events 1	0.00% 0/37	0.00% 0/42

Other adverse events

Measure	ModNal n=45 participants at risk Nal + Mod Naltrexone: 150 mg daily for males; 100 mg daily for females Modafinil: 400 mg daily	Naltrexone and Placebo n=40 participants at risk Nal Naltrexone: 150 mg daily for males; 100 mg daily for females	Modafinil and Placebo n=37 participants at risk Mod Modafinil: 400 mg daily	Double Placebo n=42 participants at risk Placebo Placebo: 400 mg and/or 100-150 mg placebo pills
Gastrointestinal disorders Nausea	24.4% 11/45	25.0% 10/40	21.6% 8/37	9.5% 4/42
Psychiatric disorders Anxiety	20.0% 9/45	5.0% 2/40	18.9% 7/37	0.00% 0/42

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

Restriction type: LTE60