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Trial record 32 of 239 for:    (armodafinil)

Modafinil vs Placebo for the Treatment of Methamphetamine Dependence (Modafinil)

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ClinicalTrials.gov Identifier: NCT00469508
Recruitment Status : Completed
First Posted : May 4, 2007
Results First Posted : March 15, 2013
Last Update Posted : March 15, 2013
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Steve Shoptaw, University of California, Los Angeles

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Methamphetamine Dependence
Interventions Drug: Modafinil
Drug: Placebo
Enrollment 71
Recruitment Details Study participants were 71 MA-dependent outpatients seeking treatment in the Los Angeles area recruitment from 4/07-9/08. Potential study participants were recruited from the community using advertisements for a study of experimental medications for MA dependence.
Pre-assignment Details Subjects completed medical and psychiatric screening (to exclude any non-drug related Axis I disorder) and baseline assessments over a two-week/six-visit lead in.
Arm/Group Title Modafinil Placebo
Hide Arm/Group Description Modafinil 400mg oral dose taken daily for 12 weeks Modafinil 0mg (sugar pill) oral dose taken daily for 12 weeks
Period Title: Overall Study
Started 34 37
Completed 14 13
Not Completed 20 24
Arm/Group Title Modafinil Placebo Total
Hide Arm/Group Description Modafinil 400mg oral dose taken daily for 12 weeks Modafinil 0mg (sugar pill) oral dose taken daily for 12 weeks Total of all reporting groups
Overall Number of Baseline Participants 34 37 71
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 37 participants 71 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
34
 100.0%
37
 100.0%
71
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 34 participants 37 participants 71 participants
39.1  (11.1) 37.8  (10.1) 38.4  (10.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 37 participants 71 participants
Female
9
  26.5%
12
  32.4%
21
  29.6%
Male
25
  73.5%
25
  67.6%
50
  70.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 34 participants 37 participants 71 participants
34 37 71
1.Primary Outcome
Title Clean Urine Drug Screen
Hide Description Urine samples, collected thrice weekly, were tested for metabolites of MA using radioimmunoassay. Each subject had a possible of 36 urine drug screens to provide during the 12 weeks of medication. An aggregate measure of urine drug screen results was calculated - the Treatment Effectiveness Score (TES) - which is the average of the sum of MA-free urine specimens provided during the treatment period by participants in each treatment condition.
Time Frame From randomization to end of week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat
Arm/Group Title Modafinil Placebo
Hide Arm/Group Description:
Modafinil 400mg oral dose taken daily for 12 weeks
Modafinil 0mg (sugar pill) oral dose taken daily for 12 weeks
Overall Number of Participants Analyzed 34 37
Overall Number of Units Analyzed
Type of Units Analyzed: Urine drug screens
590 564
Mean (Standard Deviation)
Unit of Measure: Clean urine drug screens
13.1  (11.5) 12.7  (13.2)
2.Secondary Outcome
Title Retention
Hide Description The number of persons who completed the medication phase of the trial (12 weeks of medication).
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat
Arm/Group Title Modafinil Placebo
Hide Arm/Group Description:
Modafinil 400mg oral dose taken daily for 12 weeks
Modafinil 0mg (sugar pill) oral dose taken daily for 12 weeks
Overall Number of Participants Analyzed 34 37
Measure Type: Number
Unit of Measure: participants
14 13
3.Other Pre-specified Outcome
Title VAS Score
Hide Description To measure methamphetamine craving, mean change in craving based on visual analog scale (VAS) from 0 (not at all) to 100 (extremely) from baseline to the last week of observation during the 12 week treatment period. The last observation was carried forward if not available during week 12.
Time Frame baseline and last observation during the 12 week treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat, LOCF
Arm/Group Title Modafinil Placebo
Hide Arm/Group Description:
Modafinil 400mg oral dose taken daily for 12 weeks
Modafinil 0mg (sugar pill) oral dose taken daily for 12 weeks
Overall Number of Participants Analyzed 34 37
Mean (Standard Deviation)
Unit of Measure: units on a scale
-32.5  (33.8) -47.3  (32.6)
4.Other Pre-specified Outcome
Title BDI Score
Hide Description Self-reported depression: mean change on Beck Depression Index (BDI-II) assessed weekly during the 12 week medication phase. If the week12 measure was not available, the last observation was carried forward. 0 indicates no depression, 63 is the maximum indicating severe depression.
Time Frame From baseline to end of treatment period (week 12).
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat, LOCF
Arm/Group Title Modafinil Placebo
Hide Arm/Group Description:
Modafinil 400mg oral dose taken daily for 12 weeks
Modafinil 0mg (sugar pill) oral dose taken daily for 12 weeks
Overall Number of Participants Analyzed 34 37
Mean (Standard Deviation)
Unit of Measure: units on a scale
-11.8  (12.9) -7  (11.2)
Time Frame Adverse events (AEs) were assessed at each study visit during the 12 weeks of treatment and in the follow up period (4 weeks).
Adverse Event Reporting Description Subjects were questioned at each clinic visit about their general health. Any physical or clinical change or illness, whether or not considered study drug related, was recorded on the medical record chart and adverse event case report form.In case of an adverse event thought to reflect drug-related toxicity, evaluation and management ensued.
 
Arm/Group Title Modafinil Placebo
Hide Arm/Group Description Modafinil 400mg oral dose taken daily for 12 weeks Modafinil 0mg (sugar pill) oral dose taken daily for 12 weeks
All-Cause Mortality
Modafinil Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Modafinil Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/34 (8.82%)      1/37 (2.70%)    
Ear and labyrinth disorders     
Otitis media  1 [1]  1/34 (2.94%)  1 0/37 (0.00%)  0
Infections and infestations     
Injection site abscess  1 [2]  1/34 (2.94%)  1 0/37 (0.00%)  0
Psychiatric disorders     
Psychosis  1 [3]  0/34 (0.00%)  0 1/37 (2.70%)  1
Skin and subcutaneous tissue disorders     
Acute Epididymitis  1 [2]  1/34 (2.94%)  1 0/37 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, COSTART
[1]
Not study drug related.
[2]
Not study drug related
[3]
Not study drug related - MA induced
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Modafinil Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   33/34 (97.06%)      36/37 (97.30%)    
Cardiac disorders     
Blood Pressure Increased  1  1/34 (2.94%)  1 1/37 (2.70%)  1
Heartbeats Increased  1  1/34 (2.94%)  2 2/37 (5.41%)  2
Palpitation  1  2/34 (5.88%)  2 0/37 (0.00%)  0
Tachycardia  1  1/34 (2.94%)  1 0/37 (0.00%)  0
Ear and labyrinth disorders     
Earache  1  1/34 (2.94%)  1 0/37 (0.00%)  0
Ears Feel Clogged  1  0/34 (0.00%)  0 1/37 (2.70%)  1
Hearing decreased  1  1/34 (2.94%)  1 0/37 (0.00%)  0
Eye disorders     
Conjunctivitis  1  1/34 (2.94%)  1 0/37 (0.00%)  0
Eye Irritation  1  1/34 (2.94%)  1 0/37 (0.00%)  0
Gastrointestinal disorders     
Abdominal Pain  1  0/34 (0.00%)  0 1/37 (2.70%)  1
Bowel Incontinena  1  1/34 (2.94%)  1 1/37 (2.70%)  1
Diarrhea  1  1/34 (2.94%)  1 1/37 (2.70%)  3
Dyspepsia  1  1/34 (2.94%)  1 0/37 (0.00%)  0
Gastroenteritis  1  1/34 (2.94%)  1 0/37 (0.00%)  0
Heartburn  1  1/34 (2.94%)  1 1/37 (2.70%)  1
Nausea  1  7/34 (20.59%)  7 4/37 (10.81%)  5
Vomiting  1  1/34 (2.94%)  1 1/37 (2.70%)  1
General disorders     
Agitation  1  1/34 (2.94%)  1 1/37 (2.70%)  1
Anxiety  1  5/34 (14.71%)  5 1/37 (2.70%)  1
Aphasia  1  1/34 (2.94%)  1 0/37 (0.00%)  0
Back Pain  1  1/34 (2.94%)  2 2/37 (5.41%)  2
Chest Pain  1  1/34 (2.94%)  1 0/37 (0.00%)  0
CHEST PAIN-L ARM  1  1/34 (2.94%)  1 0/37 (0.00%)  0
Chest tightness of  1  0/34 (0.00%)  0 1/37 (2.70%)  1
Chills  1  0/34 (0.00%)  0 1/37 (2.70%)  1
Concentration Imparied  1  1/34 (2.94%)  1 0/37 (0.00%)  0
Depression  1  2/34 (5.88%)  2 2/37 (5.41%)  2
Diaphoresis  1  0/34 (0.00%)  0 1/37 (2.70%)  1
Dizziness  1  0/34 (0.00%)  0 1/37 (2.70%)  1
Drowsiness  1  1/34 (2.94%)  1 0/37 (0.00%)  0
Drug withdrawal syndrome  1 [1]  1/34 (2.94%)  1 1/37 (2.70%)  1
Dry Mouth  1  3/34 (8.82%)  3 0/37 (0.00%)  0
Fatigue  1  1/34 (2.94%)  1 2/37 (5.41%)  2
Fever  1  1/34 (2.94%)  1 1/37 (2.70%)  1
Flank Pain  1  0/34 (0.00%)  0 1/37 (2.70%)  1
Flu-like symptoms  1  3/34 (8.82%)  3 1/37 (2.70%)  1
Head contusion  1  1/34 (2.94%)  1 1/37 (2.70%)  1
Headache  1  10/34 (29.41%)  14 6/37 (16.22%)  10
Herpes Simplex  1  1/34 (2.94%)  2 0/37 (0.00%)  0
Hot Flashes  1  2/34 (5.88%)  2 0/37 (0.00%)  0
Hyperactivity  1  3/34 (8.82%)  6 1/37 (2.70%)  1
Insomnia  1  10/34 (29.41%)  18 7/37 (18.92%)  8
Irritability  1  1/34 (2.94%)  1 2/37 (5.41%)  2
Jitterniness  1  4/34 (11.76%)  9 0/37 (0.00%)  0
Lethargy  1  0/34 (0.00%)  0 1/37 (2.70%)  1
Light-headed  1  2/34 (5.88%)  2 0/37 (0.00%)  0
MENTAL CONCENTRATION DIFFICULTY  1  1/34 (2.94%)  1 0/37 (0.00%)  0
Nerve pain  1  1/34 (2.94%)  1 0/37 (0.00%)  0
Nervousness  1  1/34 (2.94%)  1 0/37 (0.00%)  0
Nightmares  1  1/34 (2.94%)  1 2/37 (5.41%)  4
Nosebleed  1  1/34 (2.94%)  1 0/37 (0.00%)  0
Shakiness  1  1/34 (2.94%)  1 1/37 (2.70%)  1
Shortness of breath  1  1/34 (2.94%)  1 0/37 (0.00%)  0
Sinus Headache  1  0/34 (0.00%)  0 1/37 (2.70%)  1
Sore Throat  1  4/34 (11.76%)  4 0/37 (0.00%)  0
Stomach pain  1  1/34 (2.94%)  1 0/37 (0.00%)  0
Tightness of chest  1  0/34 (0.00%)  0 1/37 (2.70%)  1
Vision Blurred  1  1/34 (2.94%)  1 0/37 (0.00%)  0
Visual disturbance  1  0/34 (0.00%)  0 1/37 (2.70%)  1
Vivid Dreams  1  1/34 (2.94%)  1 0/37 (0.00%)  0
Wakefulness  1  0/34 (0.00%)  0 1/37 (2.70%)  1
Immune system disorders     
Pneumonia  1  1/34 (2.94%)  1 0/37 (0.00%)  0
Infections and infestations     
Abscess Gum  1  1/34 (2.94%)  1 0/37 (0.00%)  0
Infection Upper Respiratory  1  2/34 (5.88%)  2 1/37 (2.70%)  1
Tinea  1 [2]  0/34 (0.00%)  0 1/37 (2.70%)  1
Musculoskeletal and connective tissue disorders     
Joint Ache  1  1/34 (2.94%)  1 1/37 (2.70%)  1
Leg cramps  1  0/34 (0.00%)  0 1/37 (2.70%)  1
MUSCULAR WEAKNESS  1  1/34 (2.94%)  1 0/37 (0.00%)  0
Myalgia  1  2/34 (5.88%)  3 0/37 (0.00%)  0
Pain muscle  1  0/34 (0.00%)  0 1/37 (2.70%)  1
Pain neck  1  1/34 (2.94%)  1 0/37 (0.00%)  0
Psychiatric disorders     
Anger  1  1/34 (2.94%)  1 0/37 (0.00%)  0
Delusions  1  1/34 (2.94%)  1 1/37 (2.70%)  1
Hallucitation Auditory  1  1/34 (2.94%)  1 0/37 (0.00%)  0
Suicidal ideation  1  1/34 (2.94%)  1 0/37 (0.00%)  0
Reproductive system and breast disorders     
GENITALIA EXTERNAL PAINFUL  1  1/34 (2.94%)  1 0/37 (0.00%)  0
Libido Decreased  1  0/34 (0.00%)  0 1/37 (2.70%)  1
Respiratory, thoracic and mediastinal disorders     
Asthma  1  1/34 (2.94%)  1 0/37 (0.00%)  0
Bronchitis  1  1/34 (2.94%)  2 0/37 (0.00%)  0
Common Cold  1  1/34 (2.94%)  1 1/37 (2.70%)  1
Congestion Nasal  1  3/34 (8.82%)  3 0/37 (0.00%)  0
Coughing  1  5/34 (14.71%)  6 0/37 (0.00%)  0
Sexual Dysfunction  1  1/34 (2.94%)  1 0/37 (0.00%)  0
Sinus Congestion  1  1/34 (2.94%)  1 0/37 (0.00%)  0
Skin and subcutaneous tissue disorders     
Bruise  1  1/34 (2.94%)  1 0/37 (0.00%)  0
Dermatitis  1  0/34 (0.00%)  0 1/37 (2.70%)  1
Dry Skin  1  0/34 (0.00%)  0 1/37 (2.70%)  1
Pruritus  1  0/34 (0.00%)  0 1/37 (2.70%)  1
Rash  1  2/34 (5.88%)  2 2/37 (5.41%)  2
Rash Impetiginous  1  0/34 (0.00%)  0 1/37 (2.70%)  1
Skin irritation  1  0/34 (0.00%)  0 1/37 (2.70%)  1
Social circumstances     
Fracture Bone  1  0/34 (0.00%)  0 1/37 (2.70%)  1
Laceration  1  1/34 (2.94%)  1 1/37 (2.70%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, COSTART
[1]
Craving
[2]
Ringworm
study is powered to detect at least a moderate effect for modafinil (d = 0.50) in the overall sample; subgroups may be more meaningful
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Steven Shoptaw PhD
Organization: UCLA Center for Behavioral and Addiction Medicine
Phone: 310 794 0619 ext 225
Responsible Party: Steve Shoptaw, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00469508     History of Changes
Obsolete Identifiers: NCT00462293
Other Study ID Numbers: P50DA018185-03 ( U.S. NIH Grant/Contract )
P50DA018185 ( U.S. NIH Grant/Contract )
First Submitted: May 3, 2007
First Posted: May 4, 2007
Results First Submitted: December 7, 2012
Results First Posted: March 15, 2013
Last Update Posted: March 15, 2013