Modafinil and Naltrexone to Reduce Cocaine and Alcohol Dependence (Mod-Nal)

• ClinicalTrials.gov Identifier: NCT00142818
• Recruitment Status: Completed
• First Posted: September 2, 2005
• Results First Posted: August 29, 2014
• Last Update Posted: July 16, 2020
• Sponsor: Kyle Kampman
• Collaborator: National Institute on Drug Abuse (NIDA)
• Information provided by (Responsible Party): Kyle Kampman, University of Pennsylvania

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Conditions: Alcohol-Related Disorders; Alcoholism; Cocaine-Related Disorders
• Interventions: Drug: Naltrexone; Drug: Modafinil; Drug: Placebo
• Enrollment: 164

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	ModNal	Naltrexone and Placebo	Modafinil and Placebo	Double Placebo
Arm/Group Description	Nal + Mod Naltrexone: 150 mg daily for males; 100 mg daily for females Modafinil: 400 mg daily	Nal Naltrexone: 150 mg daily for males; 100 mg daily for females	Mod Modafinil: 400 mg daily	Placebo Placebo: 400 mg and/or 100-150 mg placebo pills
Period Title: Overall Study
Started	45	40	37	42
Completed	28	19	24	20
Not Completed	17	21	13	22

Baseline Characteristics

Arm/Group Title		ModNal	Naltrexone and Placebo	Modafinil and Placebo	Double Placebo	Total
Arm/Group Description		Nal + Mod Naltrexone: 150 mg daily for males; 100 mg daily for females Modafinil: 400 mg daily	Nal Naltrexone: 150 mg daily for males; 100 mg daily for females	Mod Modafinil: 400 mg daily	Placebo Placebo: 400 mg and/or 100-150 mg placebo pills	Total of all reporting groups
Overall Number of Baseline Participants		45	40	37	42	164
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	45 participants	40 participants	37 participants	42 participants	164 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	45 100.0%	40 100.0%	37 100.0%	42 100.0%	164 100.0%
	>=65 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	45 participants	40 participants	37 participants	42 participants	164 participants
	Female	15 33.3%	5 12.5%	7 18.9%	14 33.3%	41 25.0%
	Male	30 66.7%	35 87.5%	30 81.1%	28 66.7%	123 75.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	45 participants	40 participants	37 participants	42 participants	164 participants
		45	40	37	42	164

Outcome Measures

1. Primary Outcome

Title	Cocaine Use (Measured by Timeline Follow Back and Urine Screen From Week 2-week 14)
Description	[Not Specified]
Time Frame	13 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ModNal	Naltrexone and Placebo	Modafinil and Placebo	Double Placebo
Arm/Group Description:	Nal + Mod Naltrexone: 150 mg daily for males; 100 mg daily for females Modafinil: 400 mg daily	Nal Naltrexone: 150 mg daily for males; 100 mg daily for females	Mod Modafinil: 400 mg daily	Placebo Placebo: 400 mg and/or 100-150 mg placebo pills
Overall Number of Participants Analyzed	45	40	37	42
Mean (Standard Deviation); Unit of Measure: number of cocaine negative urine samples
	9.3 (8.4)	7.2 (8.1)	10.1 (9.4)	10.5 (9.9)

2. Primary Outcome

Title	Percent Days of Heavy Drinking (Measured by Timeline Follow Back Starting at Week Two Through Week 14
Description	[Not Specified]
Time Frame	13 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Modafinil Plus Naltrexone	Naltrexone	Modafinil	Placebo
Arm/Group Description:	Nal + Mod Naltrexone: 150 mg daily for males; 100 mg daily for females Modafinil: 400 mg daily	Nal Naltrexone: 150 mg daily for males; 100 mg daily for females	Mod Modafinil: 400 mg daily	Placebo Placebo: 400 mg and/or 100-150 mg placebo pills
Overall Number of Participants Analyzed	45	40	37	42
Mean (Standard Error); Unit of Measure: mean percentage of days
	34.7 (4.4)	35.1 (4.2)	33.6 (4.2)	33.8 (4.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Modafinil Plus Naltrexone, Naltrexone, Modafinil, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.4
	Comments	[Not Specified]
	Method	ANOVA
	Comments	[Not Specified]

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	ModNal		Naltrexone and Placebo		Modafinil and Placebo		Double Placebo
Arm/Group Description	Nal + Mod Naltrexone: 150 mg daily for males; 100 mg daily for females Modafinil: 400 mg daily		Nal Naltrexone: 150 mg daily for males; 100 mg daily for females		Mod Modafinil: 400 mg daily		Placebo Placebo: 400 mg and/or 100-150 mg placebo pills
All-Cause Mortality
	ModNal		Naltrexone and Placebo		Modafinil and Placebo		Double Placebo
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--		--/--		--/--
Serious Adverse Events
	ModNal		Naltrexone and Placebo		Modafinil and Placebo		Double Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/45 (24.44%)		6/40 (15.00%)		6/37 (16.22%)		11/42 (26.19%)
General disorders
Hospitalization † 1	7/45 (15.56%)	9	3/40 (7.50%)	3	3/37 (8.11%)	3	7/42 (16.67%)	11
Exacerbation of cocaine and alcohol † 1	4/45 (8.89%)	4	2/40 (5.00%)	2	3/37 (8.11%)	3	6/42 (14.29%)	6
Psychiatric disorders
Depression or Hallucinations † 1	1/45 (2.22%)	1	0/40 (0.00%)	0	0/37 (0.00%)	0	1/42 (2.38%)	1
Social circumstances
Arrested for Homicide † 1	0/45 (0.00%)	0	1/40 (2.50%)	1	0/37 (0.00%)	0	0/42 (0.00%)	0
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA (10.0)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	ModNal		Naltrexone and Placebo		Modafinil and Placebo		Double Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/45 (24.44%)		10/40 (25.00%)		8/37 (21.62%)		4/42 (9.52%)
Gastrointestinal disorders
Nausea † 1	11/45 (24.44%)		10/40 (25.00%)		8/37 (21.62%)		4/42 (9.52%)
Psychiatric disorders
Anxiety † 1	9/45 (20.00%)		2/40 (5.00%)		7/37 (18.92%)		0/42 (0.00%)
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA (10.0)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS 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.

Results Point of Contact

• Name/Title: Dr. Kyle Kampman
• Organization: University of Pennsylvania
• Phone: 215-222-3200 ext 109
• EMail: kampman@mail.med.upenn.edu

• Responsible Party: Kyle Kampman, University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT00142818
• Other Study ID Numbers: NIDA-12756-3; P50DA012756-03 ( U.S. NIH Grant/Contract ); DPMC ( Other Identifier: NIDA )
• First Submitted: September 1, 2005
• First Posted: September 2, 2005
• Results First Submitted: August 12, 2014
• Results First Posted: August 29, 2014
• Last Update Posted: July 16, 2020