Trial Outcomes & Findings for SSRI and Buprenorphine (NCT NCT00475878)

NCT ID: NCT00475878

Last Updated: 2012-04-03

Results Overview

Drop-out is defined as 7 or more days of missed Buprenorphine doses

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 147 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2012-04-03

Participant Flow

Participant milestones

Measure	Placebo placebo pill, daily for 12 weeks, for individuals entering buprenorphine treatment for opioid dependence	10 mg Escitalopram 10 mg escitalopram pill, daily for 12 weeks, for individuals entering buprenorphine treatment for opioid dependence
Overall Study STARTED	75	72
Overall Study COMPLETED	75	72
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

SSRI and Buprenorphine

Baseline characteristics by cohort

Measure	Placebo n=75 Participants placebo pill, daily for 12 weeks, for individuals entering buprenorphine treatment for opioid dependence	10 mg Escitalopram n=72 Participants 10 mg escitalopram pill, daily for 12 weeks, for individuals entering buprenorphine treatment for opioid dependence	Total n=147 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
Age, Categorical Between 18 and 65 years	75 Participants n=5 Participants	72 Participants n=7 Participants	147 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	36.8 years STANDARD_DEVIATION 9.8 • n=5 Participants	38.3 years STANDARD_DEVIATION 9.6 • n=7 Participants	37.5 years STANDARD_DEVIATION 9.9 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	17 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	57 Participants n=5 Participants	55 Participants n=7 Participants	112 Participants n=5 Participants
Region of Enrollment United States	75 participants n=5 Participants	72 participants n=7 Participants	147 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Participants who were fully eligible for the study, completed the enrollment process and began study medication were used in an intent to treat analysis.

Drop-out is defined as 7 or more days of missed Buprenorphine doses

Outcome measures

Measure	10 mg Escitalopram n=72 Participants in a double-blind, randomized controlled trial, participants were given 10mg escitalopram prior to buprenorphine induction	Placebo n=75 Participants in a double-blind, randomized controlled trial, participants were given placebo prior to buprenorphine induction
Percentage of Participants Who Dropped Out of Buprenorphine Treatment	33.3 percentage of participants	44.0 percentage of participants

SECONDARY outcome

Timeframe: 3 months

Population: participants who were fully eligible for the study, completed the enrollment process and began study medication were included in an intent to treat analysis

Depressive symptoms, as measured by self-report during study interviews, using the Beck Depression Inventory II. Scores ranged from 0-63; higher scores indicate more depressive symptoms.

Outcome measures

Measure	10 mg Escitalopram n=72 Participants in a double-blind, randomized controlled trial, participants were given 10mg escitalopram prior to buprenorphine induction	Placebo n=75 Participants in a double-blind, randomized controlled trial, participants were given placebo prior to buprenorphine induction
Depressive Symptoms	12.31 units on a scale Standard Error 1.79	11.35 units on a scale Standard Error 1.46

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

10 mg Escitalopram

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=75 participants at risk placebo pill, daily for 12 weeks, for individuals entering buprenorphine treatment for opioid dependence	10 mg Escitalopram n=72 participants at risk 10 mg escitalopram pill, daily for 12 weeks, for individuals entering buprenorphine treatment for opioid dependence
Psychiatric disorders increasing clinical symptoms	1.3% 1/75 • Number of events 1 • adverse event information was collected at each study appointment, which occurred every 1-2 weeks throughout participant's 12-week study participation. adverse event information was collected via structured questionnaires and by the study physician during bi-weekly medication visits.	0.00% 0/72 • adverse event information was collected at each study appointment, which occurred every 1-2 weeks throughout participant's 12-week study participation. adverse event information was collected via structured questionnaires and by the study physician during bi-weekly medication visits.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Michael Stein

Butler Hospital

Phone: 401-455-6646

Email: michael_stein@brown.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place