Depression, Opiate Dependence
Conditions
Keywords
opiate use, depression, buprenorphine, escitalopram
Brief summary
This study is designed to test whether treatment of depressive symptoms using escitalopram improves adherence to Buprenorphine and reduces symptoms of depression for individuals receiving Buprenorphine through their medical provider.
Detailed description
Participants interested in receiving Buprenorphine will be offered the opportunity to enroll in this study. Enrolled study participants will complete interviews at baseline and again every two weeks for a total of 8 interviews over 3 months. In this double-blind randomized controlled trial, participants will either receive a placebo or escitalopram (10mg). All participants will also be followed by their Buprenorphine clinic medical provider. Questions during the face-to-face interviews will assess mood, drug craving, pain, sleep, medication adherence and drug-related experiences. Comparison(s): Participants randomized into the medication component of the study as compared to participants randomized into the placebo component of the study.
Interventions
DRUGescitalopram
10mg escitalopram/day for 3 months
DRUGplacebo
placebo capsule/day for 3 months
Sponsors
Butler Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* opiate dependence * Ham-D \> 14
Exclusion criteria
* no psychiatric contraindications to using escitalopram * no medical contraindications to using escitalopram * methadone dose \< 30 * no current SSRI use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Dropped Out of Buprenorphine Treatment | 3 months | Drop-out is defined as 7 or more days of missed Buprenorphine doses |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depressive Symptoms | 3 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo placebo pill, daily for 12 weeks, for individuals entering buprenorphine treatment for opioid dependence | 75 |
| 10 mg Escitalopram 10 mg escitalopram pill, daily for 12 weeks, for individuals entering buprenorphine treatment for opioid dependence | 72 |
| Total | 147 |
Baseline characteristics
| Characteristic | 10 mg Escitalopram | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 72 Participants | 75 Participants | 147 Participants |
| Age Continuous | 38.3 years STANDARD_DEVIATION 9.6 | 36.8 years STANDARD_DEVIATION 9.8 | 37.5 years STANDARD_DEVIATION 9.9 |
| Region of Enrollment United States | 72 participants | 75 participants | 147 participants |
| Sex: Female, Male Female | 17 Participants | 18 Participants | 35 Participants |
| Sex: Female, Male Male | 55 Participants | 57 Participants | 112 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 75 | 0 / 72 |
| serious Total, serious adverse events | 1 / 75 | 0 / 72 |
Outcome results
Primary
Percentage of Participants Who Dropped Out of Buprenorphine Treatment
Drop-out is defined as 7 or more days of missed Buprenorphine doses
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 10 mg Escitalopram | Percentage of Participants Who Dropped Out of Buprenorphine Treatment | 33.3 percentage of participants |
| Placebo | Percentage of Participants Who Dropped Out of Buprenorphine Treatment | 44.0 percentage of participants |
p-value: 0.1995% CI: [0.33, 1.24]Chi-squared
Secondary
Depressive Symptoms
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.
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 10 mg Escitalopram | Depressive Symptoms | 12.31 units on a scale | Standard Error 1.79 |
| Placebo | Depressive Symptoms | 11.35 units on a scale | Standard Error 1.46 |
p-value: 0.1895% CI: [-2.79, 5.84]t-test, 2 sided