NCT02423018

Brief Summary

The purpose of this study is to determine if a single dose of pregabalin 300mg in patients receiving medications for sedative-hypnotic withdrawal symptoms will produce meaningful differences in measures of "drug liking" and "drug high" as compared to placebo.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2015

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

April 15, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 22, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 23, 2016

Status Verified

March 1, 2016

Enrollment Period

11 months

First QC Date

April 15, 2015

Last Update Submit

March 21, 2016

Conditions

Substance-Related Disorders

Outcome Measures

Primary Outcomes (1)

  • Change from baseline on Visual Analogue Scale for "Drug Liking" over 5 hours post-dose administration

    On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose

Secondary Outcomes (18)

  • Profile of Mood States (POMS)

    On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose

  • Psychomotor Performance (Digit Symbol Substitution Test (DSST)

    On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose

  • Visual Analogue Scale for "Take Drug Again"

    On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose

  • Visual Analogue Scale for "Any Drug Effects"

    On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose

  • Visual Analogue Scale for "Good Effects"

    On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose

  • +13 more secondary outcomes

Other Outcomes (6)

  • Change in score on the Benzodiazepine Withdrawal Symptom Questionnaire

    Day 0, then twice daily on Days 1 to 10 (i.e., directly before 8am dose and 3pm)

  • Change in score on the six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory (STAI)

    Day 0, then twice daily on Days 1 to 10 (i.e., directly before 8am dose and 3pm)

  • Clinical Global Impression Scale - Severity

    Day 0

  • +3 more other outcomes

Study Arms (2)

Pregabalin

ACTIVE COMPARATOR

Pregabalin titrated up to, and tapered from, 225mg/day in divided doses for 10 days

Drug: PregabalinDrug: Placebo

Placebo

PLACEBO COMPARATOR

Placebo for 10 days

Drug: PregabalinDrug: Placebo

Interventions

PregabalinDRUG

In replacement of their morning 75mg pregabalin or placebo dose on Days 6 and 8, all participants will receive either a single dose of 300mg of pregabalin or placebo, in a randomized, double-blind, crossover manner. This is when steady state concentrations of pregabalin occur.

Also known as: Lyrica
PlaceboPregabalin
PlaceboDRUG

In replacement of their morning 75mg pregabalin or placebo dose on Days 6 and 8, all participants will receive either a single dose of 300mg of pregabalin or placebo, in a randomized, double-blind, crossover manner. This is when steady state concentrations of pregabalin occur.

PlaceboPregabalin

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Admitted to the Medical Withdrawal Unit at the Centre for Addiction and Mental Health for medically assisted withdrawal from benzodiazepines, zopiclone and/or zolpidem
  • Willing and capable to give written informed consent

You may not qualify if:

  • Patients who are hypersensitive to pregabalin or to any ingredient in the formulation or component of the container.
  • Pregnant or nursing women
  • Renal impairment (creatinine clearance less than 60ml/min)
  • History of angioedema, or taking drugs associated with angioedema (e.g., ACE-inhibitors).
  • Currently taking pregabalin or gabapentin
  • Currently taking thiazolidinedione antidiabetic agents (e.g., rosiglitazone, pioglitazone)
  • Previous history of pregabalin or gabapentin abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5S 3M2, Canada

Location

Related Links

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Beth Sproule, PharmD

    Centre for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinician Scientist

Study Record Dates

First Submitted

April 15, 2015

First Posted

April 22, 2015

Study Start

April 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

March 23, 2016

Record last verified: 2016-03

Locations

CA(1)