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Trial record 69 of 239 for:    (armodafinil)

Modafinil for Smoked Cocaine Self-Administration

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ClinicalTrials.gov Identifier: NCT01778010
Recruitment Status : Completed
First Posted : January 29, 2013
Results First Posted : January 9, 2018
Last Update Posted : January 9, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
New York State Psychiatric Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Cocaine Dependence
Interventions Drug: Modafinil 0 mg
Drug: Modafinil 200 mg
Drug: Modafinil 400 mg
Drug: Cocaine 0 mg
Drug: Cocaine 12 mg
Drug: Cocaine 25 mg
Drug: Cocaine 50 mg
Enrollment 8
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Modafinil + Cocaine
Hide Arm/Group Description During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and underwent a dose response of smoked cocaine (0, 12, 25, and 50mg).
Period Title: Overall Study
Started 13
Completed 8
Not Completed 5
Reason Not Completed
Withdrawal by Subject             2
abnormal ECG before meds             1
Arrested             1
rash while on placebo             1
Arm/Group Title Modafinil + Cocaine
Hide Arm/Group Description During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
<=18 years
0
   0.0%
Between 18 and 65 years
8
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants
38.5  (2.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
1
  12.5%
Male
7
  87.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants
8
1.Primary Outcome
Title Cocaine Self-administration
Hide Description The number of purchased cocaine doses as a function of cocaine dose and modafinil maintenance condition.
Time Frame 48 days
Hide Outcome Measure Data
Hide Analysis Population Description
Eight patients contributed to each condition, in a within-subjects manner.
Arm/Group Title Modafinil 0mg + Cocaine 0mg Modafinil 200mg + Cocaine 0mg Modafinil 400mg + Cocaine 0mg Modafinil 0mg + Cocaine 12mg Modafinil 200mg + Cocaine 12mg Modafinil 400mg + Cocaine 12mg Modafinil 0mg + Cocaine 25mg Modafinil 200mg + Cocaine 25mg Modafinil 400mg + Cocaine 25mg Modafinil 0mg + Cocaine 50mg Modafinil 200mg + Cocaine 50mg Modafinil 400mg + Cocaine 50mg
Hide Arm/Group Description:
During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
Overall Number of Participants Analyzed 8 8 8 8 8 8 8 8 8 8 8 8
Mean (Standard Error)
Unit of Measure: Number of doses purchased
0  (0) 0  (0) 0  (0) 2.2  (0.3) 1.5  (0.3) 2.1  (0.1) 4.1  (0.2) 2.5  (0.3) 2.6  (0.3) 4.5  (0.1) 3.5  (0.3) 3  (0.3)
2.Secondary Outcome
Title Drug Quality Cluster
Hide Description

Visual analogue scale ratings on the ‘Drug Quality’ cluster as a function of cocaine dose and modafinil maintenance condition. A cluster score was derived by taking the arithmetic average of the items in the cluster. Scores range from 0-100, with higher scores indicating greater agreement with the term. The "Drug Quality Cluster" consisted of three items:

  1. "the choice was of high quality"
  2. "the choice was potent"
  3. "I liked the choice" Higher scores indicate increasing agreement with the statement, which would indicate a poorer outcome.
Time Frame 48 days
Hide Outcome Measure Data
Hide Analysis Population Description
Eight subjects participants in each condition in a within-subjects fashion.
Arm/Group Title Modafinil 0mg + Cocaine 0mg Modafinil 200mg + Cocaine 0mg Modafinil 400mg + Cocaine 0mg Modafinil 0mg + Cocaine 12mg Modafinil 200mg + Cocaine 12mg Modafinil 400mg + Cocaine 12mg Modafinil 0mg + Cocaine 25mg Modafinil 200mg + Cocaine 25mg Modafinil 400mg + Cocaine 25mg Modafinil 0mg + Cocaine 50mg Modafinil 200mg + Cocaine 50mg Modafinil 400mg + Cocaine 50mg
Hide Arm/Group Description:
During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
Overall Number of Participants Analyzed 8 8 8 8 8 8 8 8 8 8 8 8
Mean (Standard Error)
Unit of Measure: units on a scale
2  (0.5) 2  (0.5) 2  (0.5) 30  (5) 28  (4) 29  (3) 44  (4) 35  (4) 35  (2) 60  (3) 55  (4) 55  (4)
3.Secondary Outcome
Title Heart Rate
Time Frame 48 days
Hide Outcome Measure Data
Hide Analysis Population Description
Eight patients participated in each condition in a within-subjects fashion.
Arm/Group Title Modafinil 0mg + Cocaine 0mg Modafinil 200mg + Cocaine 0mg Modafinil 400mg + Cocaine 0mg Modafinil 0mg + Cocaine 12mg Modafinil 200mg + Cocaine 12mg Modafinil 400mg + Cocaine 12mg Modafinil 0mg + Cocaine 25mg Modafinil 200mg + Cocaine 25mg Modafinil 400mg + Cocaine 25mg Modafinil 0mg + Cocaine 50mg Modafinil 200mg + Cocaine 50mg Modafinil 400mg + Cocaine 50mg
Hide Arm/Group Description:
During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
Overall Number of Participants Analyzed 8 8 8 8 8 8 8 8 8 8 8 8
Mean (Standard Error)
Unit of Measure: BPM
88  (2) 86  (2) 91  (2) 102  (3) 101  (2.5) 97  (3) 130.5  (2) 110  (3) 115  (2.5) 141  (2) 125  (4) 122  (2)
Time Frame 48 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Modafinil 0 mg + Cocaine (0, 12, 25, and 50mg) Modafinil 200 mg + Cocaine (0, 12, 25, and 50mg) Modafinil 400 mg + Cocaine (0, 12, 25, and 50mg)
Hide Arm/Group Description During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (0 mg/day) and a dose response of four doses of smoked cocaine (0, 12, 25, and 50mg). During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (200 mg/day) and a dose response of four doses of smoked cocaine (0, 12, 25, and 50mg). During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (400 mg/day) and a dose response of four doses of smoked cocaine (0, 12, 25, and 50mg).
All-Cause Mortality
Modafinil 0 mg + Cocaine (0, 12, 25, and 50mg) Modafinil 200 mg + Cocaine (0, 12, 25, and 50mg) Modafinil 400 mg + Cocaine (0, 12, 25, and 50mg)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/8 (0.00%)   0/8 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Modafinil 0 mg + Cocaine (0, 12, 25, and 50mg) Modafinil 200 mg + Cocaine (0, 12, 25, and 50mg) Modafinil 400 mg + Cocaine (0, 12, 25, and 50mg)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/8 (0.00%)   0/8 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Modafinil 0 mg + Cocaine (0, 12, 25, and 50mg) Modafinil 200 mg + Cocaine (0, 12, 25, and 50mg) Modafinil 400 mg + Cocaine (0, 12, 25, and 50mg)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/8 (0.00%)   0/8 (0.00%) 
This study is limited by the small, non-diverse sample.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Margaret Haney, Ph.D.
Organization: New York State Psychiatric Institute at Columbia University Medical Center
Phone: 646-774-6153
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01778010     History of Changes
Other Study ID Numbers: 5738
R01DA023650 ( U.S. NIH Grant/Contract )
First Submitted: January 24, 2013
First Posted: January 29, 2013
Results First Submitted: August 8, 2017
Results First Posted: January 9, 2018
Last Update Posted: January 9, 2018