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Effectiveness of Modafinil and D-amphetamine in Treating Cocaine Dependent Individuals

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ClinicalTrials.gov Identifier: NCT00218062
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : June 21, 2017
Last Update Posted : June 21, 2017
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Joy Schmitz, The University of Texas Health Science Center, Houston

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Cocaine-Related Disorders
Interventions Drug: D-Amphetamine 30mg
Drug: D-Amphetamine 60mg
Drug: Modafinil 200mg
Drug: Modafinil 400mg
Behavioral: Therapy
Drug: Placebo
Enrollment 73
Recruitment Details  
Pre-assignment Details  
Arm/Group Title D-Amphetamine 60mg + Therapy Modafinil 400mg + Therapy Modafinil 200mg + D-Amphetamine 30mg + Therapy Placebo + Therapy
Hide Arm/Group Description

During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. d-Amphetamine sustained release (SR) (Dexedrine Spansules) started at 15 mg (day 1–2), increased to 30mg (day3; 15mg, BID), 45mg (day4; 15mg, TID), and 60mg (day5; 15mg bid plus 30mg qd). A 5-day dose reduction schedule occurred at week 17.

Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.

During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. Modafinil started at 200mg (day1) and increased to 400mg (days2–5). A 5-day dose reduction schedule occurred at week 17.

Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.

During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. For the combination condition, dosages of modafinil and d-amphetamine were escalated to one-half of that for the single medication conditions. A 5-day dose reduction schedule occurred at week 17.

Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.

During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance.

Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.

Period Title: Overall Study
Started 22 20 15 16
Received First Dose of Study Medication 16 11 10 12
Completed 7 4 3 3
Not Completed 15 16 12 13
Arm/Group Title D-Amphetamine 60mg + Therapy Modafinil 400mg + Therapy Modafinil 200mg + D-Amphetamine 30mg + Therapy Placebo + Therapy Total
Hide Arm/Group Description

During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. d-Amphetamine SR (Dexedrine Spansules) started at 15 mg (day 1–2), increased to 30mg (day3; 15mg, BID), 45mg (day4; 15mg, TID), and 60mg (day5; 15mg bid plus 30mg qd). A 5-day dose reduction schedule occurred at week 17.

Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.

During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. Modafinil started at 200mg (day1) and increased to 400mg (days2–5). A 5-day dose reduction schedule occurred at week 17.

Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.

During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. For the combination condition, dosages of modafinil and d-amphetamine were escalated to one-half of that for the single medication conditions. A 5-day dose reduction schedule occurred at week 17.

Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.

During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance.

Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.

Total of all reporting groups
Overall Number of Baseline Participants 22 20 15 16 73
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 20 participants 15 participants 16 participants 73 participants
44.3  (6.5) 42.6  (8.3) 41.2  (8.5) 41.9  (9) 42  (8.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 20 participants 15 participants 16 participants 73 participants
Female
1
   4.5%
4
  20.0%
4
  26.7%
2
  12.5%
11
  15.1%
Male
21
  95.5%
16
  80.0%
11
  73.3%
14
  87.5%
62
  84.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants 20 participants 15 participants 16 participants 73 participants
22 20 15 16 73
1.Primary Outcome
Title Cocaine Use as Assessed by the Treatment Effectiveness Score (TES), Which is the Total Number of Cocaine-negative Urines During Treatment
Hide Description [Not Specified]
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received the first dose of study medication were included in this analysis.
Arm/Group Title D-Amphetamine 60mg + Therapy Modafinil 400mg + Therapy Modafinil 200mg + D-Amphetamine 30mg + Therapy Placebo + Therapy
Hide Arm/Group Description:

During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. d-Amphetamine SR (Dexedrine Spansules) started at 15 mg (day 1–2), increased to 30mg (day3; 15mg, BID), 45mg (day4; 15mg, TID), and 60mg (day5; 15mg bid plus 30mg qd). A 5-day dose reduction schedule occurred at week 17.

Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.

During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. Modafinil started at 200mg (day1) and increased to 400mg (days2–5). A 5-day dose reduction schedule occurred at week 17.

Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.

During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. For the combination condition, dosages of modafinil and d-amphetamine were escalated to one-half of that for the single medication conditions. A 5-day dose reduction schedule occurred at week 17.

Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.

During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance.

Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.

Overall Number of Participants Analyzed 16 11 10 12
Mean (Standard Deviation)
Unit of Measure: number of cocaine negative urines
9.25  (13.45) 6.09  (8.12) 6  (7.73) 4.91  (7.56)
2.Primary Outcome
Title Retention as Indicated by the Number of Participants Who Completed 16 Weeks of Treatment
Hide Description [Not Specified]
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title D-Amphetamine 60mg + Therapy Modafinil 400mg + Therapy Modafinil 200mg + D-Amphetamine 30mg + Therapy Placebo + Therapy
Hide Arm/Group Description:

During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. d-Amphetamine SR (Dexedrine Spansules) started at 15 mg (day 1–2), increased to 30mg (day3; 15mg, BID), 45mg (day4; 15mg, TID), and 60mg (day5; 15mg bid plus 30mg qd). A 5-day dose reduction schedule occurred at week 17.

Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.

During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. Modafinil started at 200mg (day1) and increased to 400mg (days2–5). A 5-day dose reduction schedule occurred at week 17.

Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.

During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. For the combination condition, dosages of modafinil and d-amphetamine were escalated to one-half of that for the single medication conditions. A 5-day dose reduction schedule occurred at week 17.

Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.

During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance.

Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.

Overall Number of Participants Analyzed 22 20 15 16
Measure Type: Number
Unit of Measure: participants
7 4 3 3
3.Primary Outcome
Title Retention as Indicated by the Number of Participants Who Remained in the Study
Hide Description [Not Specified]
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title D-Amphetamine 60mg + Therapy Modafinil 400mg + Therapy Modafinil 200mg + D-Amphetamine 30mg + Therapy Placebo + Therapy
Hide Arm/Group Description:

During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. d-Amphetamine SR (Dexedrine Spansules) started at 15 mg (day 1–2), increased to 30mg (day3; 15mg, BID), 45mg (day4; 15mg, TID), and 60mg (day5; 15mg bid plus 30mg qd). A 5-day dose reduction schedule occurred at week 17.

Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.

During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. Modafinil started at 200mg (day1) and increased to 400mg (days2–5). A 5-day dose reduction schedule occurred at week 17.

Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.

During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. For the combination condition, dosages of modafinil and d-amphetamine were escalated to one-half of that for the single medication conditions. A 5-day dose reduction schedule occurred at week 17.

Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.

During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance.

Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.

Overall Number of Participants Analyzed 22 20 15 16
Measure Type: Number
Unit of Measure: participants
7 4 3 3
4.Secondary Outcome
Title Medication Compliance as Indicated by Percentage of Pills Taken According to Self-report
Hide Description [Not Specified]
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title D-Amphetamine 60mg + Therapy Modafinil 400mg + Therapy Modafinil 200mg + D-Amphetamine 30mg + Therapy Placebo + Therapy
Hide Arm/Group Description:

During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. d-Amphetamine SR (Dexedrine Spansules) started at 15 mg (day 1–2), increased to 30mg (day3; 15mg, BID), 45mg (day4; 15mg, TID), and 60mg (day5; 15mg bid plus 30mg qd). A 5-day dose reduction schedule occurred at week 17.

Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.

During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. Modafinil started at 200mg (day1) and increased to 400mg (days2–5). A 5-day dose reduction schedule occurred at week 17.

Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.

During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. For the combination condition, dosages of modafinil and d-amphetamine were escalated to one-half of that for the single medication conditions. A 5-day dose reduction schedule occurred at week 17.

Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.

During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance.

Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.

Overall Number of Participants Analyzed 22 20 15 16
Measure Type: Number
Unit of Measure: percentage of pills taken
80.2 34.5 65.8 73.2
5.Secondary Outcome
Title Medication Compliance as Indicated by Percentage of Riboflavin-positive Urine Samples
Hide Description [Not Specified]
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title D-Amphetamine 60mg + Therapy Modafinil 400mg + Therapy Modafinil 200mg + D-Amphetamine 30mg + Therapy Placebo + Therapy
Hide Arm/Group Description:

During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. d-Amphetamine SR (Dexedrine Spansules) started at 15 mg (day 1–2), increased to 30mg (day3; 15mg, BID), 45mg (day4; 15mg, TID), and 60mg (day5; 15mg bid plus 30mg qd). A 5-day dose reduction schedule occurred at week 17.

Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.

During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. Modafinil started at 200mg (day1) and increased to 400mg (days2–5). A 5-day dose reduction schedule occurred at week 17.

Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.

During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. For the combination condition, dosages of modafinil and d-amphetamine were escalated to one-half of that for the single medication conditions. A 5-day dose reduction schedule occurred at week 17.

Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.

During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance.

Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.

Overall Number of Participants Analyzed 22 20 15 16
Measure Type: Number
Unit of Measure: % of riboflavin-positive urine samples
67.1 70 76.8 66.7
Time Frame 16 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title D-Amphetamine 60mg + Therapy Modafinil 400mg + Therapy Modafinil 200mg + D-Amphetamine 30mg + Therapy Placebo + Therapy
Hide Arm/Group Description

During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. d-Amphetamine SR (Dexedrine Spansules) started at 15 mg (day 1–2), increased to 30mg (day3; 15mg, BID), 45mg (day4; 15mg, TID), and 60mg (day5; 15mg bid plus 30mg qd). A 5-day dose reduction schedule occurred at week 17.

Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.

During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. Modafinil started at 200mg (day1) and increased to 400mg (days2–5). A 5-day dose reduction schedule occurred at week 17.

Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.

During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. For the combination condition, dosages of modafinil and d-amphetamine were escalated to one-half of that for the single medication conditions. A 5-day dose reduction schedule occurred at week 17.

Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.

During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance.

Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master’s-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.

All-Cause Mortality
D-Amphetamine 60mg + Therapy Modafinil 400mg + Therapy Modafinil 200mg + D-Amphetamine 30mg + Therapy Placebo + Therapy
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
D-Amphetamine 60mg + Therapy Modafinil 400mg + Therapy Modafinil 200mg + D-Amphetamine 30mg + Therapy Placebo + Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/22 (0.00%)      0/20 (0.00%)      0/15 (0.00%)      0/16 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
D-Amphetamine 60mg + Therapy Modafinil 400mg + Therapy Modafinil 200mg + D-Amphetamine 30mg + Therapy Placebo + Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/22 (4.55%)      3/20 (15.00%)      2/15 (13.33%)      0/16 (0.00%)    
Cardiac disorders         
Chest pain   1/22 (4.55%)  1 1/20 (5.00%)  1 0/15 (0.00%)  0 0/16 (0.00%)  0
Change in electrocardiogram (EKG)   0/22 (0.00%)  0 0/20 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0
Gastrointestinal disorders         
Constipation   0/22 (0.00%)  0 0/20 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0
Infections and infestations         
Pneumonia   0/22 (0.00%)  0 1/20 (5.00%)  1 0/15 (0.00%)  0 0/16 (0.00%)  0
Vascular disorders         
Migraine   0/22 (0.00%)  0 1/20 (5.00%)  1 0/15 (0.00%)  0 0/16 (0.00%)  0
Indicates events were collected by systematic assessment
High attrition; Pill-taking burden (3 capsules daily) contributed to medication non-compliance; Small sample size.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Joy M. Schmitz
Organization: The University of Texas Health Science Center at Houston
Phone: (713) 486-2867
EMail: Joy.M.Schmitz@uth.tmc.edu
Layout table for additonal information
Responsible Party: Joy Schmitz, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00218062     History of Changes
Other Study ID Numbers: NIDA-09262-12
P50DA009262-12 ( U.S. NIH Grant/Contract )
DPMC ( Other Identifier: NIDA )
First Submitted: September 16, 2005
First Posted: September 22, 2005
Results First Submitted: May 24, 2017
Results First Posted: June 21, 2017
Last Update Posted: June 21, 2017