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Pharmacotherapy & CM for Opioid and Cocaine Dependence

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00838981
First received: February 6, 2009
Last updated: August 10, 2017
Last verified: May 2017
Results First Received: May 5, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Cocaine Dependence
Interventions: Drug: Modafinil
Drug: Sugar Pill
Behavioral: Contingency Management
Drug: Methadone
Behavioral: cognitive behavioral treatment
Behavioral: Voucher Control

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Adult male and female participants were recruited from the Greater New Haven area from May 2008 to March 2014 by word-of-mouth, flyers and from referrals from treatment centers in the local area. The study was conducted in an outpatient clinic of the West Haven VA Hospital.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After eligibility was determined, participants were randomized to placebo, 200mg up to 400mg of modafinil.The study consisted of three phases that involve: 1) a one or two week “induction” phase, 2) an eleven-week "treatment" phase; and 3) a four week "taper, detoxification or transfer" phase.

Reporting Groups
  Description
Modafinil Plus Contingency Management

Modafinil from 200mg up to 400mg

Modafinil: Modafinil will be phase in from 200mg to 400mg

Modafinil Plus Voucher Control Modafinil from 200mg up to 400mg plus the voucher control
Placebo Plus Voucher Control Sugar pill plus voucher control
Placebo Plus Contingency Management Sugar pill plus contingency management

Participant Flow for 2 periods

Period 1:   Week 1 Days 1-3
    Modafinil Plus Contingency Management   Modafinil Plus Voucher Control   Placebo Plus Voucher Control   Placebo Plus Contingency Management
STARTED   26   19   27   19 
COMPLETED   26   19   27   19 
NOT COMPLETED   0   0   0   0 

Period 2:   Day 4 to Week 11
    Modafinil Plus Contingency Management   Modafinil Plus Voucher Control   Placebo Plus Voucher Control   Placebo Plus Contingency Management
STARTED   26   19   27   19 
Completed Main Treatment on 400mg   22   13   17   14 
COMPLETED   19   11   16   12 
NOT COMPLETED   7   8   11   7 



  Baseline Characteristics
  Hide 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
Modafinil Plus CM

Modafinil from 200mg up to 400mg

Modafinil: Modafinil will be phase in from 200mg to 400mg

Modafinil Plus Voucher Control

Modafinil from 200mg up to 400mg

Modafinil: Modafinil will be phase in from 200mg to 400mg

Sugar Pill Plus CM

Placebo: sugar pill

Sugar Pill: placebo, sugar pill will mirror active drug

Sugar Pill Plus Voucher Control

Placebo: sugar pill

Sugar Pill: placebo, sugar pill will mirror active drug

Total Total of all reporting groups

Baseline Measures
   Modafinil Plus CM   Modafinil Plus Voucher Control   Sugar Pill Plus CM   Sugar Pill Plus Voucher Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 26   19   19   27   91 
Age 
[Units: Participants]
Count of Participants
         
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      26 100.0%      19 100.0%      19 100.0%      27 100.0%      91 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Participants]
Mean (Standard Deviation)
 38.9  (10.8)   41.5  (9.7)   34.5  (10.2)   38.2  (11.4)   38.3  (10.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      7  26.9%      9  47.4%      6  31.6%      11  40.7%      33  36.3% 
Male      19  73.1%      10  52.6%      13  68.4%      16  59.3%      58  63.7% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
         
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      5  19.2%      4  21.1%      3  15.8%      4  14.8%      16  17.6% 
White      20  76.9%      10  52.6%      14  73.7%      15  55.6%      59  64.8% 
More than one race      1   3.8%      5  26.3%      2  10.5%      8  29.6%      16  17.6% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
         
United States   26   19   19   27   91 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Average Number of Positive Urine Tests   [ Time Frame: up to 12 weeks. ]

2.  Primary:   Average Maximum Days Abstinent   [ Time Frame: up to 84 days ]

3.  Secondary:   Average Number of Days Using a Substance Within Treatment   [ Time Frame: up to 90 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Mehmet Sofuoglu, M.D.,Ph.D.
Organization: Yale University
phone: 203-937-4809
e-mail: mehmet.sofuoglu@yale.edu



Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00838981     History of Changes
Other Study ID Numbers: 0705002636
R01DA021264 ( U.S. NIH Grant/Contract )
DPMC ( Other Identifier: NIDA )
Study First Received: February 6, 2009
Results First Received: May 5, 2017
Last Updated: August 10, 2017