ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
D-Amphetamine 60mg + Therapy

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.

Modafinil 400mg + Therapy

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.

Modafinil 200mg + D-Amphetamine 30mg + Therapy

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.

Placebo + Therapy

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.


Participant Flow:   Overall Study
    D-Amphetamine 60mg + Therapy   Modafinil 400mg + Therapy   Modafinil 200mg + D-Amphetamine 30mg + Therapy   Placebo + Therapy
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 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
D-Amphetamine 60mg + Therapy

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.

Modafinil 400mg + Therapy

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.

Modafinil 200mg + D-Amphetamine 30mg + Therapy

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.

Placebo + Therapy

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 Total of all reporting groups

Baseline Measures
   D-Amphetamine 60mg + Therapy   Modafinil 400mg + Therapy   Modafinil 200mg + D-Amphetamine 30mg + Therapy   Placebo + Therapy   Total 
Overall Participants Analyzed 
[Units: Participants]
 22   20   15   16   73 
Age 
[Units: Years]
Mean (Standard Deviation)
 44.3  (6.5)   42.6  (8.3)   41.2  (8.5)   41.9  (9)   42  (8.1) 
Sex: Female, Male 
[Units: Participants]
Count of 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 
[Units: Participants]
         
United States   22   20   15   16   73 


  Outcome Measures

1.  Primary:   Cocaine Use as Assessed by the Treatment Effectiveness Score (TES), Which is the Total Number of Cocaine-negative Urines During Treatment   [ Time Frame: 16 weeks ]

2.  Primary:   Retention as Indicated by the Number of Participants Who Completed 16 Weeks of Treatment   [ Time Frame: 16 weeks ]

3.  Primary:   Retention as Indicated by the Number of Participants Who Remained in the Study   [ Time Frame: 16 weeks ]

4.  Secondary:   Medication Compliance as Indicated by Percentage of Pills Taken According to Self-report   [ Time Frame: 16 weeks ]

5.  Secondary:   Medication Compliance as Indicated by Percentage of Riboflavin-positive Urine Samples   [ Time Frame: 16 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
High attrition; Pill-taking burden (3 capsules daily) contributed to medication non-compliance; Small sample size.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr Joy M. Schmitz
Organization: The University of Texas Health Science Center at Houston
phone: (713) 486-2867
e-mail: Joy.M.Schmitz@uth.tmc.edu


Publications of Results:

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