Trial Outcomes & Findings for Clinical Efficacy of Sertraline Augmented With Gabapentin in Depressed, Recently Abstinent Cocaine-dependent Humans (NCT NCT00654953)

Last Updated: 2011-04-25

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

102 participants

Primary outcome timeframe

70 days

Results posted on

2011-04-25

Participant Flow

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.

Of the 143 screened, 42 failed randomization/screening procedures and so were not randomized to receive study medication or placebo.

Participant milestones

Participant milestones
Measure	Placebo Group Placebo capsules	Active Group: Sertraline Alone sertraline (200 mg/day)	Active Group: Sertraline Plus Gabapentin sertraline (200 mg/day) plus gabapentin (1,200 mg/day)
Overall Study STARTED	36	36	30
Overall Study COMPLETED	6	8	8
Overall Study NOT COMPLETED	30	28	22

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Group n=36 Participants Placebo capsules	Active Group: Sertraline Alone n=36 Participants sertraline (200 mg/day)	Active Group: Sertraline Plus Gabapentin n=30 Participants sertraline (200 mg/day) plus gabapentin (1,200 mg/day)	Total n=102 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	36 Participants n=5 Participants	36 Participants n=7 Participants	30 Participants n=5 Participants	102 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age Continuous	38.74 years STANDARD_DEVIATION 6.32 • n=5 Participants	39.78 years STANDARD_DEVIATION 8.36 • n=7 Participants	39.40 years STANDARD_DEVIATION 7.81 • n=5 Participants	39.31 years STANDARD_DEVIATION 7.48 • n=4 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	10 Participants n=7 Participants	6 Participants n=5 Participants	28 Participants n=4 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	26 Participants n=7 Participants	24 Participants n=5 Participants	74 Participants n=4 Participants
Region of Enrollment United States	36 participants n=5 Participants	36 participants n=7 Participants	30 participants n=5 Participants	102 participants n=4 Participants

PRIMARY outcome

Timeframe: 70 days

Population: Participants who completed the two-week residential stay and had 2 urine samples consecutively positive for cocaine were included in the analysis.

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.

Outcome measures

Outcome measures
Measure	Placebo n=30 urine samples	Sertraline n=30 urine samples	Sertraline Plus Gabapentin n=30 urine samples
Urine Toxicology Screens for the Presence of Cocaine/Cocaine Metabolites	19.93 Days to relapse (two consec coc+ urines) Standard Deviation 12.16	23.38 Days to relapse (two consec coc+ urines) Standard Deviation 17.82	17.27 Days to relapse (two consec coc+ urines) Standard Deviation 14.49

Adverse Events

Placebo Group

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Active Group: Sertraline Alone

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Active Group: Sertraline Plus Gabapentin

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo Group n=36 participants at risk Placebo capsules	Active Group: Sertraline Alone n=36 participants at risk sertraline (200 mg/day)	Active Group: Sertraline Plus Gabapentin n=30 participants at risk sertraline (200 mg/day) plus gabapentin (1,200 mg/day)
Immune system disorders Allergic Reaction	0.00% 0/36	0.00% 0/36	3.3% 1/30 • Number of events 1

Other adverse events

Other adverse events
Measure	Placebo Group n=36 participants at risk Placebo capsules	Active Group: Sertraline Alone n=36 participants at risk sertraline (200 mg/day)	Active Group: Sertraline Plus Gabapentin n=30 participants at risk sertraline (200 mg/day) plus gabapentin (1,200 mg/day)
Reproductive system and breast disorders sexual dysfunction	2.8% 1/36 • Number of events 1	11.1% 4/36 • Number of events 4	0.00% 0/30
Musculoskeletal and connective tissue disorders Chest Pain	2.8% 1/36 • Number of events 1	5.6% 2/36 • Number of events 2	0.00% 0/30
Cardiac disorders dizziness	5.6% 2/36 • Number of events 2	0.00% 0/36	3.3% 1/30 • Number of events 3
Nervous system disorders headache	5.6% 2/36 • Number of events 2	2.8% 1/36 • Number of events 1	6.7% 2/30 • Number of events 2
Gastrointestinal disorders Nausea and/or Emesis	5.6% 2/36 • Number of events 2	2.8% 1/36 • Number of events 1	16.7% 5/30 • Number of events 7
Cardiac disorders High Blood Pressure	5.6% 2/36 • Number of events 3	8.3% 3/36 • Number of events 3	6.7% 2/30 • Number of events 3
Gastrointestinal disorders Diarrhea	0.00% 0/36	0.00% 0/36	6.7% 2/30 • Number of events 2
Musculoskeletal and connective tissue disorders toothache and/or tooth abscess	0.00% 0/36	2.8% 1/36 • Number of events 1	13.3% 4/30 • Number of events 4
Skin and subcutaneous tissue disorders Skin Rash	2.8% 1/36 • Number of events 1	2.8% 1/36 • Number of events 1	6.7% 2/30 • Number of events 2
Nervous system disorders Anxiety	0.00% 0/36	5.6% 2/36 • Number of events 2	0.00% 0/30
Infections and infestations Sore Throat	2.8% 1/36 • Number of events 1	5.6% 2/36 • Number of events 2	0.00% 0/30
Musculoskeletal and connective tissue disorders Yawning	0.00% 0/36	5.6% 2/36 • Number of events 2	0.00% 0/30

Additional Information

Alison Oliveto, Ph.D.

UAMS

Phone: 501-526-8441

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place