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Psychopharmacology for Cocaine Dependence - Buspirone

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Scott Lane, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01267292
First received: December 24, 2010
Last updated: May 3, 2017
Last verified: May 2017
Results First Received: February 16, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Investigator, Outcomes Assessor;   Primary Purpose: Basic Science
Condition: Cocaine Dependence
Interventions: Drug: Buspirone
Drug: Placebo for Buspirone
Drug: Methylphenidate
Drug: Placebo for Methylphenidate

  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
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
Buspirone Plus Methylphenidate [week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
Placebo for Buspirone Plus Methylphenidate [week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]

Participant Flow:   Overall Study
    Buspirone Plus Methylphenidate   Placebo for Buspirone Plus Methylphenidate
STARTED   24   26 
COMPLETED   20   20 
NOT COMPLETED   4   6 



  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.
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Reporting Groups
  Description
Buspirone Plus Methylphenidate [week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
Placebo for Buspirone Plus Methylphenidate [week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
Total Total of all reporting groups

Baseline Measures
   Buspirone Plus Methylphenidate   Placebo for Buspirone Plus Methylphenidate   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   20   40 
Age 
[Units: Years]
Mean (Standard Deviation)
 41.7  (7.82)   44.15  (7.23)   42.925  (7.525) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      18  90.0%      16  80.0%      34  85.0% 
Male      2  10.0%      4  20.0%      6  15.0% 
Region of Enrollment 
[Units: Participants]
     
United States   20   20   40 
Attentional Bias as assessed by score on the Stroop task [1] 
[Units: Milliseconds]
Mean (Standard Deviation)
 12.39759  (70.25051)   28.67933  (69.99501)   20.53846  (70.12276) 
[1] The baseline reading was assessed on Monday of week 2. Participants are instructed to respond to words shown in different colors on the screen by pressing as quickly and accurately as possible on one of three colored buttons. Attentional bias is measured as the difference in reaction times on cocaine vs. neutral words. The reported score is a difference score in milliseconds (cocaine minus neutral), in which positive means slower to respond to cocaine and thus greater attentional bias, and negative means no attentional bias to cocaine words.
Risky decision making as assessed by score on the risky decision making task [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 9.778235  (7.368139)   8.945935  (5.512101)   9.362085  (6.44012) 
[1] The baseline reading was assessed on Monday of week 2. The risky decision making task provides subjects with three choice options on each of 100 repeated trials. Options are low, moderate, and high risk, based on variance and probability in gain/loss amounts. The low risk option is more adaptive over many trials. The outcome measure is a risk index (ranging from 0.33 to 100) that factors in tolerance for variability and amount of gains and losses across the three options. 100 is highest risk. 0.33 is lowest risk.
Subjective Effects as assessed by score on the Vigor Subscale of the Profile of Mood States (POMS) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 5.989247  (6.306573)   5.080925  (5.594259)   5.535086  (5.950416) 
[1] The baseline reading was assessed on Monday of week 2. The POMS is a self-rating measure of current mood, consisting of six subscales demonstrated to be sensitive to a range of acute drug effects, including amphetamine, cocaine, and caffeine. A 37-item short form of the POMS was used, which correlates highly with the full scale. The vigor subscale is reported, and the vigor subscale score ranges from 0 to 28, with 28 representing the highest score for that mood state. The higher the value, the worse the outcome.
Subjective Effects as assessed by Score on "Feel High" Subscale of the Drug Effects Questionnaire [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 15.32065  (25.31205)   8.128655  (17.20622)   11.7246525  (21.259135) 
[1] The baseline reading was assessed on Monday of week 2. The DEQ is a visual analog scale questionnaire that assesses the extent to which subjects experience four subjective states: “Feel Drug”, “Feel High”, “Like Drug”, and “Want More”. The "Feel High" subscale is reported, and this subscale is scored on a visual analogue scale (scroll bar on computer screen) ranging from 0-100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome.
Subjective Effects as assessed by the "elated" subscale of the visual analogue scale (VAS) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 22.00538  (26.22491)   20.4593  (26.25991)   21.23234  (26.24241) 
[1] The baseline reading was assessed on Monday of week 2. The VAS presents 100-mm horizontal lines labeled with an adjective: “stimulated”, “high”, “anxious”, “elated”, “hungry”, and “nauseated.” The "elated" subscale is reported, and this sub scale is anchored by “not at all” (0) on the left and “extremely” (100) on the right, with a score range of 0-100. The higher the score, the worse the outcome.
Heart rate [1] 
[Units: Beats per minute]
Mean (Standard Deviation)
 65.42781  (11.223)   64.44886  (11.28527)   64.938335  (11.254135) 
[1] The baseline reading was assessed on Monday of week 2. Heart rate is the measure of heart beats per minute.
Systolic blood pressure [1] 
[Units: mmHg]
Mean (Standard Deviation)
 117.4813  (14.13086)   113.2727  (11.94963)   115.377  (13.040245) 
[1] The baseline reading was assessed on Monday of week 2. Systolic blood pressure is the amount of pressure in the arteries during contraction of the heart muscle.
Diastolic blood pressure [1] 
[Units: mmHg]
Mean (Standard Deviation)
 74.52406  (8.30489)   75.34091  (8.234265)   74.932485  (8.2695775) 
[1] The baseline reading was assessed on Monday of week 2. Diastolic blood pressure is the blood pressure when the heart muscle is between beats.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Attentional Bias as Assessed by Score on the Stroop Task   [ Time Frame: 1 time a day on Wednesday and Friday of week 2; 1 time a day on Monday and Wednesday of week 3 ]

2.  Primary:   Risky Decision Making as Assessed by Score on the Risky Decision Making Task   [ Time Frame: 1 time a day on Wednesday and Friday of week 2; 1 time a day on Monday and Wednesday of week 3 ]

3.  Secondary:   Subjective Effects as Assessed by the Addiction Research Center Inventory (ARCI)   [ Time Frame: 11 times a day on Wednesday and Friday of week 2; 11 times a day on Monday and Wednesday of week 3 ]

4.  Secondary:   Subjective Effects as Assessed by Score on the Vigor Subscale of the Profile of Mood States (POMS)   [ Time Frame: 11 times a day on Wednesday and Friday of week 2; 11 times a day on Monday and Wednesday of week 3 ]

5.  Secondary:   Subjective Effects as Assessed by Score on the "Feel High" Subscale of the Drug Effects Questionnaire (DEQ)   [ Time Frame: 11 times a day on Wednesday and Friday of week 2; 11 times a day on Monday and Wednesday of week 3 ]

6.  Secondary:   Subjective Effects as Assessed by the "Elated" Subscale of the Visual Analogue Scale (VAS)   [ Time Frame: 11 times a day on Wednesday and Friday of week 2; 11 times a day on Monday and Wednesday of week 3 ]

7.  Secondary:   Heart Rate   [ Time Frame: 11 times a day on Wednesday and Friday of week 2; 11 times a day on Monday and Wednesday of week 3 ]

8.  Secondary:   Systolic Blood Pressure   [ Time Frame: 11 times a day on Wednesday and Friday of week 2; 11 times a day on Monday and Wednesday of week 3 ]

9.  Secondary:   Diastolic Blood Pressure   [ Time Frame: 11 times a day on Wednesday and Friday of week 2; 11 times a day on Monday and Wednesday of week 3 ]

10.  Secondary:   Rapid Response Inhibition as Assessed by the Immediate Memory Task (IMT)   [ Time Frame: baseline ]

11.  Secondary:   Rapid Response Inhibition as Assessed by the Immediate Memory Task (IMT)   [ Time Frame: Thursday of week 1 ]

12.  Secondary:   Rapid Response Inhibition as Assessed by the Immediate Memory Task (IMT)   [ Time Frame: Monday of week 4 ]

13.  Secondary:   Reversal Learning as Assessed by Number of Perseverative Errors on the Reversal Learning Task   [ Time Frame: baseline ]

14.  Secondary:   Reversal Learning as Assessed by Number of Perseverative Errors on the Reversal Learning Task   [ Time Frame: Thursday of week 1 ]

15.  Secondary:   Reversal Learning as Assessed by Number of Perseverative Errors on the Reversal Learning Task   [ Time Frame: Monday of week 4 ]


  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
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  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: Scott Lane, PhD
Organization: The University of Texas Health Science Center at Houston
phone: 713-486-2535
e-mail: Scott.D.Lane@uth.tmc.edu



Responsible Party: Scott Lane, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01267292     History of Changes
Other Study ID Numbers: NIDA-P50-09262-Project2.1
Study First Received: December 24, 2010
Results First Received: February 16, 2017
Last Updated: May 3, 2017