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Medications for Stopping Cocaine Dependence and Preventing Relapse

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Joy Schmitz, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00218023
First received: September 16, 2005
Last updated: February 23, 2017
Last verified: February 2017
Results First Received: February 23, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Care Provider, Investigator, Outcomes Assessor;   Primary Purpose: Treatment
Conditions: Cocaine Abuse
Cocaine-Related Disorders
Interventions: Drug: Modafinil
Drug: Levodopa/Carbidopa
Drug: Naltrexone HCl
Drug: Placebo
Behavioral: Motivational Interviewing (MI)
Behavioral: Contingency management (CM)
Behavioral: Cognitive-Behavioral Therapy (CBT)

  Participant Flow
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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
Modafinil Plus MI, CM, and CBT

The modafinil dose began at 200 mg (day 1) and increased to the fixed dose of 200 mg twice daily (day 2) during the 12 weeks of Phase II.

The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.

Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).

Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II.

Levodopa/Carbidopa Plus MI, CM, and CBT

Levodopa–carbidopa, in the sustained-release formulation (Sinemet CR), began at a dose of levodopa/carbidopa 400/100 mg (day 1) and increased to the fixed dose of 400/100 mg twice daily (day 2) during the 12 weeks of Phase II.

The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.

Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).

Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II.

Naltrexone HCl Plus MI, CM, and CBT

Naltrexone hydrochloride (HCl) doses began at 25 mg (day 1) and increased to the fixed dose of 25 mg twice daily (day 2) during the 12 weeks of Phase II.

The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.

Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).

Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II.

Placebo Plus MI, CM, and CBT

Placebo capsules were identical in appearance to active drug capsules, and each contained 50 mg riboflavin for subsequent evaluation of medication compliance.

The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.

Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).

Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II.


Participant Flow:   Overall Study
    Modafinil Plus MI, CM, and CBT   Levodopa/Carbidopa Plus MI, CM, and CBT   Naltrexone HCl Plus MI, CM, and CBT   Placebo Plus MI, CM, and CBT
STARTED   22   25   16   18 
REceived Drug or Placebo in Phase II   18   24   15   18 
COMPLETED   9   10   6   11 
NOT COMPLETED   13   15   10   7 



  Baseline Characteristics
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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 MI, CM, and CBT

The modafinil dose began at 200 mg (day 1) and increased to the fixed dose of 200 mg twice daily (day 2) during the 12 weeks of Phase II.

The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.

Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).

Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II.

Levodopa/Carbidopa Plus MI, CM, and CBT

Levodopa–carbidopa, in the sustained-release formulation (Sinemet CR), began at a dose of levodopa/carbidopa 400/100 mg (day 1) and increased to the fixed dose of 400/100 mg twice daily (day 2) during the 12 weeks of Phase II.

The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.

Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).

Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II.

Naltrexone HCl Plus MI, CM, and CBT

Naltrexone hydrochloride (HCl) doses began at 25 mg (day 1) and increased to the fixed dose of 25 mg twice daily (day 2) during the 12 weeks of Phase II.

The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.

Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).

Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II.

Placebo Plus MI, CM, and CBT

Placebo capsules were identical in appearance to active drug capsules, and each contained 50 mg riboflavin for subsequent evaluation of medication compliance.

The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I.

Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II).

Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II.

Total Total of all reporting groups

Baseline Measures
   Modafinil Plus MI, CM, and CBT   Levodopa/Carbidopa Plus MI, CM, and CBT   Naltrexone HCl Plus MI, CM, and CBT   Placebo Plus MI, CM, and CBT   Total 
Overall Participants Analyzed 
[Units: Participants]
 22   25   16   18   81 
Age 
[Units: Years]
Mean (Standard Deviation)
 43.64  (5.71)   40.66  (8.6)   42.08  (9.89)   42.29  (10.5)   42.16  (8.67) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      3  13.6%      6  24.0%      4  25.0%      1   5.6%      14  17.3% 
Male      19  86.4%      19  76.0%      12  75.0%      17  94.4%      67  82.7% 
Region of Enrollment 
[Units: Participants]
         
United States   22   25   16   18   81 


  Outcome Measures
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1.  Primary:   Mean Proportion of Cocaine-positive Urines Over Course of 12 Week Treatment in Subgroup Achieving Abstinence at Baseline   [ Time Frame: 3 times per week (Monday, Wednesday, and Friday) for 12 weeks ]

2.  Primary:   Mean Proportion of Cocaine-positive Urines Over Course of 12 Week Treatment in Subgroup NOT Achieving Abstinence at Baseline   [ Time Frame: 3 times per week (Monday, Wednesday, and Friday) for 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
The sample size was small; however, the main aim of the study was achieved (i.e., to evaluate the feasibility of using a two-phase abstinence induction paradigm to screen candidate medications for cocaine treatment).


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


Results Point of Contact:  
Name/Title: Joy M. Schmitz, PhD
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: NCT00218023     History of Changes
Other Study ID Numbers: NIDA-09262-7
P50DA009262-07 ( US NIH Grant/Contract Award Number )
DPMC ( Other Identifier: NIDA )
Study First Received: September 16, 2005
Results First Received: February 23, 2017
Last Updated: February 23, 2017