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Clinical Efficacy of Sertraline Augmented With Gabapentin in Depressed, Recently Abstinent Cocaine-dependent Humans

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ClinicalTrials.gov Identifier: NCT00654953
Recruitment Status : Completed
First Posted : April 9, 2008
Results First Posted : April 25, 2011
Last Update Posted : April 25, 2011
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by:
University of Arkansas

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Cocaine Dependence
Depressive Symptoms
Interventions Drug: sertraline
Drug: Placebo
Drug: gabapentin
Enrollment 102
Recruitment Details 143 cocaine-using volunteers gave informed consent between 12/15/2005 and 4/8/2009. Consenting occurred at either the UAMS substance abuse treatment clinic, treatment research unit or center for addiction research at the UAMS Psychiatric Research Institute. Of these, 105 eligible participants were enrolled into the study proper.
Pre-assignment Details Of the 143 screened, 42 failed randomization/screening procedures and so were not randomized to receive study medication or placebo.
Arm/Group Title Placebo Group Active Group: Sertraline Alone Active Group: Sertraline Plus Gabapentin
Hide Arm/Group Description Placebo capsules sertraline (200 mg/day) sertraline (200 mg/day) plus gabapentin (1,200 mg/day)
Period Title: Overall Study
Started 36 36 30
Completed 6 8 8
Not Completed 30 28 22
Arm/Group Title Placebo Group Active Group: Sertraline Alone Active Group: Sertraline Plus Gabapentin Total
Hide Arm/Group Description Placebo capsules sertraline (200 mg/day) sertraline (200 mg/day) plus gabapentin (1,200 mg/day) Total of all reporting groups
Overall Number of Baseline Participants 36 36 30 102
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 36 participants 30 participants 102 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
36
 100.0%
36
 100.0%
30
 100.0%
102
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants 36 participants 30 participants 102 participants
38.74  (6.32) 39.78  (8.36) 39.40  (7.81) 39.31  (7.48)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 36 participants 30 participants 102 participants
Female
12
  33.3%
10
  27.8%
6
  20.0%
28
  27.5%
Male
24
  66.7%
26
  72.2%
24
  80.0%
74
  72.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 36 participants 36 participants 30 participants 102 participants
36 36 30 102
1.Primary Outcome
Title Urine Toxicology Screens for the Presence of Cocaine/Cocaine Metabolites
Hide Description Thrice-weekly urine samples were analyzed for the presence of cocaine/cocaine metabolite. Days to Relapse was defined as time to the second of two urine results consecutively positive for cocaine.
Time Frame 70 days
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed the two-week residential stay and had 2 urine samples consecutively positive for cocaine were included in the analysis.
Arm/Group Title Placebo Sertraline Sertraline Plus Gabapentin
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 14 8 11
Overall Number of Units Analyzed
Type of Units Analyzed: Urine samples
30 30 30
Mean (Standard Deviation)
Unit of Measure: Days to relapse (two consec coc+ urines)
19.93  (12.16) 23.38  (17.82) 17.27  (14.49)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Sertraline, Sertraline Plus Gabapentin
Comments The analysis tested the null hypothesis of no difference among groups in terms of the # of days to relapse (first two conseqcutively positive urines) using ANOVA.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method ANOVA
Comments degrees of freedom for medication group = 2 (group)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Group Active Group: Sertraline Alone Active Group: Sertraline Plus Gabapentin
Hide Arm/Group Description Placebo capsules sertraline (200 mg/day) sertraline (200 mg/day) plus gabapentin (1,200 mg/day)
All-Cause Mortality
Placebo Group Active Group: Sertraline Alone Active Group: Sertraline Plus Gabapentin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Group Active Group: Sertraline Alone Active Group: Sertraline Plus Gabapentin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/36 (0.00%)      0/36 (0.00%)      1/30 (3.33%)    
Immune system disorders       
Allergic Reaction  [1]  0/36 (0.00%)  0 0/36 (0.00%)  0 1/30 (3.33%)  1
Indicates events were collected by systematic assessment
[1]
Allergic reaction to study medication
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Group Active Group: Sertraline Alone Active Group: Sertraline Plus Gabapentin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/36 (19.44%)      17/36 (47.22%)      14/30 (46.67%)    
Cardiac disorders       
dizziness * [1]  2/36 (5.56%)  2 0/36 (0.00%)  0 1/30 (3.33%)  3
High Blood Pressure   2/36 (5.56%)  3 3/36 (8.33%)  3 2/30 (6.67%)  3
Gastrointestinal disorders       
Nausea and/or Emesis *  2/36 (5.56%)  2 1/36 (2.78%)  1 5/30 (16.67%)  7
Diarrhea *  0/36 (0.00%)  0 0/36 (0.00%)  0 2/30 (6.67%)  2
Infections and infestations       
Sore Throat *  1/36 (2.78%)  1 2/36 (5.56%)  2 0/30 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Chest Pain  [2]  1/36 (2.78%)  1 2/36 (5.56%)  2 0/30 (0.00%)  0
toothache and/or tooth abscess  0/36 (0.00%)  0 1/36 (2.78%)  1 4/30 (13.33%)  4
Yawning *  0/36 (0.00%)  0 2/36 (5.56%)  2 0/30 (0.00%)  0
Nervous system disorders       
headache *  2/36 (5.56%)  2 1/36 (2.78%)  1 2/30 (6.67%)  2
Anxiety *  0/36 (0.00%)  0 2/36 (5.56%)  2 0/30 (0.00%)  0
Reproductive system and breast disorders       
sexual dysfunction * [3]  1/36 (2.78%)  1 4/36 (11.11%)  4 0/30 (0.00%)  0
Skin and subcutaneous tissue disorders       
Skin Rash   1/36 (2.78%)  1 1/36 (2.78%)  1 2/30 (6.67%)  2
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
[1]
self-reported dizziness
[2]
Chest pain in which cardiac involvement was ruled out.
[3]
erectile dysfunction/impotence/inability or delayed orgasm
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: Alison Oliveto, Ph.D.
Organization: UAMS
Phone: 501-526-8441
Responsible Party: Alison Oliveto Beaudoin, UAMS
ClinicalTrials.gov Identifier: NCT00654953     History of Changes
Other Study ID Numbers: P50DA018197 ( U.S. NIH Grant/Contract )
P50DA018197 ( U.S. NIH Grant/Contract )
DPMCDA
First Submitted: April 4, 2008
First Posted: April 9, 2008
Results First Submitted: March 28, 2011
Results First Posted: April 25, 2011
Last Update Posted: April 25, 2011