Substance-Related DisordersPhase 4NCT02423018
Abuse Liability of Pregabalin and Its Effects on Benzodiazepine Withdrawal Symptoms
A Phase 4 study testing Pregabalin in people with Substance-Related Disorders, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Substance-Related Disorders
- What is being tested?
- Pregabalin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2015to Mar 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Pregabalin's Abuse Liability and Its Effects on Benzodiazepine Withdrawal Symptoms in Inpatients Undergoing Medically Assisted Benzodiazepine Withdrawal
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.
Read the detailed description
Pregabalin is currently being explored as a pharmacotherapy for substance use disorders. Open-labeled, uncontrolled studies indicate modest efficacy of pregabalin in benzodiazepine withdrawal symptom management and as a long-term benzodiazepine dependence treatment. Concurrently, there is increasing information from case reports and adverse drug event registries regarding pregabalin abuse in patients with substance use disorders.
Given that the abuse liability of pregabalin has not been clearly established, nor its effects on benzodiazepine withdrawal symptoms in inpatients, this study is a randomized, double-blind, placebo-controlled, cross-over, abuse liability study of a single dose of pregabalin 300mg, nested within a randomized,double-blind placebo-controlled, feasibility study evaluating pregabalin's effects on withdrawal symptoms in inpatients undergoing medically-assisted withdrawal from benzodiazepine, zopiclone or zolpidem.
- Conditions
- Substance-Related Disorders
- Being tested
- Pregabalin, Placebo
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
Also called Lyrica
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin | Active comparator | Pregabalin titrated up to, and tapered from, 225mg/day in divided doses for 10 days Receives: Drug: Pregabalin; Drug: Placebo |
| Placebo | Placebo comparator | Placebo for 10 days Receives: Drug: Pregabalin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline on Visual Analogue Scale for "Drug Liking" over 5 hours post-dose administration
Measured: 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)
Measured: 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)
Digit Symbol Substitution Test (DSST)
Measured: 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"
Measured: 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"
Measured: 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"
Measured: On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose
Visual Analogue Scale for "Bad Effects"
Measured: On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose
Visual Analogue Scale for "Feel Sick"
Measured: On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose
Visual Analogue Scale for "Nausea"
Measured: On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose
Visual Analogue Scale for "Sleepy"
Measured: On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose
Visual Analogue Scale for "Dizzy"
Measured: On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose
Sedation (Addiction Research Center Inventory (ARCI)
Addiction Research Center Inventory (ARCI)
Measured: On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose
Euphoria (Addiction Research Center Inventory (ARCI)
Addiction Research Center Inventory (ARCI)
Measured: On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose
Dysphoric Changes (Addiction Research Center Inventory (ARCI)
Addiction Research Center Inventory (ARCI)
Measured: On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose
Psychotomimetic Changes (Addiction Research Center Inventory (ARCI)
Addiction Research Center Inventory (ARCI)
Measured: On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose
Somatic Disturbances (Addiction Research Center Inventory (ARCI)
Addiction Research Center Inventory (ARCI)
Measured: On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose
Sensory Disturbances (Addiction Research Center Inventory (ARCI)
Addiction Research Center Inventory (ARCI)
Measured: On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose
Tmax Estimated peak plasma pregabalin concentration
Estimated peak plasma pregabalin concentration
Measured: On Days 6 and 8 only: obtained 1 hour post-dose
Change from baseline on Visual Analogue Scale for "Drug High" over 5 hours
Additional Primary Outcome
Measured: On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionMar 2016
- Study completionMar 2016
Why it stopped: Low enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance-Related DisordersStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beth Sproule, Centre for Addiction and Mental Health
- Investigators
- Beth Sproule, PharmD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02423018
- Sponsor's protocol ID
- 079-2014
- Status last verified
- Mar 2016
- First submitted
- 15 Apr 2015
- Last updated
- 23 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pregabalin's Abuse Liability and Its Effects on Benzodiazepine Withdrawal Symptoms in Inpatients Undergoing Medically Assisted Benzodiazepine Withdrawal
- ClinicalTrials.gov ID
- NCT02423018
- Acronym / sponsor ID
- 079-2014
- Conditions
- Substance-Related Disorders
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 22 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Pregabalin is currently being explored as a pharmacotherapy for substance use disorders. Open-labeled, uncontrolled studies indicate modest efficacy of pregabalin in benzodiazepine withdrawal symptom management and as a long-term benzodiazepine dependence treatment. Concurrently, there is increasing information from case reports and adverse drug event registries regarding pregabalin abuse in patients with substance use disorders.
Given that the abuse liability of pregabalin has not been clearly established, nor its effects on benzodiazepine withdrawal symptoms in inpatients, this study is a randomized, double-blind, placebo-controlled, cross-over, abuse liability study of a single dose of pregabalin 300mg, nested within a randomized,double-blind placebo-controlled, feasibility study evaluating pregabalin's effects on withdrawal symptoms in inpatients undergoing medically-assisted withdrawal from benzodiazepine, zopiclone or zolpidem.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregabalin | Active comparator | Drug: Pregabalin, Drug: PlaceboPregabalin titrated up to, and tapered from, 225mg/day in divided doses for 10 days |
| Placebo | Placebo comparator | Drug: Pregabalin, Drug: PlaceboPlacebo for 10 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PregabalinAlso: LyricaIn 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. | Drug | Placebo, Pregabalin |
| PlaceboIn 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. | Drug | Placebo, Pregabalin |
Primary outcome
Change from baseline on Visual Analogue Scale for "Drug Liking" over 5 hours post-dose administration
Time frame: On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose
18 secondary outcomes
Profile of Mood States (POMS)
Time frame: 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)
Time frame: 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"
Time frame: 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"
Time frame: 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"
Time frame: On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose
Visual Analogue Scale for "Bad Effects"
Time frame: On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose
Visual Analogue Scale for "Feel Sick"
Time frame: On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose
Visual Analogue Scale for "Nausea"
Time frame: On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose
Visual Analogue Scale for "Sleepy"
Time frame: On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose
Visual Analogue Scale for "Dizzy"
Time frame: On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose
Sedation (Addiction Research Center Inventory (ARCI)
Time frame: On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose
Euphoria (Addiction Research Center Inventory (ARCI)
Time frame: On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose
Dysphoric Changes (Addiction Research Center Inventory (ARCI)
Time frame: On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose
Psychotomimetic Changes (Addiction Research Center Inventory (ARCI)
Time frame: On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose
Somatic Disturbances (Addiction Research Center Inventory (ARCI)
Time frame: On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose
Sensory Disturbances (Addiction Research Center Inventory (ARCI)
Time frame: On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose
Tmax Estimated peak plasma pregabalin concentration
Time frame: On Days 6 and 8 only: obtained 1 hour post-dose
Change from baseline on Visual Analogue Scale for "Drug High" over 5 hours
Time frame: On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose
Results and safety
The study was stopped early (reason given: Low enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2016.
- The Centre for Addiction and Mental Health (CAMH) is the leading mental health and addictions research facility in Canada, and one of the largest in the world.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beth Sproule, PharmD principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pregabalin in people with Substance-Related Disorders, run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Low enrollment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline on Visual Analogue Scale for "Drug Liking" over 5 hours post-dose administration (time frame: On Days 6 and 8 only: Baseline (0), and at 1, 2, 2.5, 3, 4, 5 hours post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2016.