Cannabis DependencePhase 2NCT00974376
Gabapentin Treatment of Cannabis Dependence
A Phase 2 study testing gabapentin 1200mg/day and Manual-guided behavioral counseling in people with Cannabis Dependence and Cannabis Withdrawal, run by The Scripps Research Institute at 1 site in United States.
Trial summary
This is a clinical study to evaluate the efficacy of the medication gabapentin in treating persons with cannabis dependence. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cannabis Dependence, Cannabis Withdrawal, Cognitive Deficits
- What is being tested?
- gabapentin 1200mg/day and Manual-guided behavioral counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2009to 19 May 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Males or females from 18-65 years of age
- Meets DSM IV criteria for current cannabis dependence
- Seeking research-based outpatient treatment for cannabis dependence that involves daily medication
- Smoked MJ daily at least 25 days per month during the 90 days prior to randomization
- At least a 2-year history of regular MJ use
Who cannot join
- Abstinent from cannabis more than 2 days at the time of randomization
- Active suicidal ideation
- Currently meets DSM IV criteria for abuse or dependence on other substances, or has urine drug screen positive for substances, other than cannabis or nicotine
- Significant medical disorders that will increase potential risk or interfere with study participation,
- Sexually active female participants with childbearing potential who are pregnant, nursing or refuse to use a reliable method of birth control
- Meets DSM IV criteria for a major AXIS I disorder other than cannabis and nicotine dependence,
Show all 10Show fewer
- Inability to understand and/or comply with the provisions of the protocol and consent form
- Treatment with an investigational drug during the previous month
- Sensitivity to study drug as evidenced by adverse drug experiences with gabapentin or its ingredients
- Ongoing treatment with medications that may affect study outcomes
Trial locations and contacts
1 site in 1 country.
United States1 site
The Scripps Research Institute
La Jolla, California, 92037
About this study
This is a clinical study to evaluate the efficacy of the medication gabapentin in treating persons with cannabis dependence.
Read the detailed description
This is a 12-week, double blind, placebo controlled study to evaluate the efficacy of gabapentin in treating outpatients with cannabis dependence. After an initial phone screen, a comprehensive screening visit is scheduled to determine eligibility. Upon enrollment, counseling, medication dispensation and research assessments occur 1 time per week for 3 months.
- Conditions
- Cannabis Dependence, Cannabis Withdrawal, Cognitive Deficits
- Being tested
- gabapentin 1200mg/day, Placebo, Manual-guided behavioral counseling
- Keywords
- Cannabis Treatment, Cannabis Use, Cannabis Dependence, Executive Functioning, Cognitive Deficits
- Medical subject headings
- Marijuana Abuse, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gabapentin 1200mg/dayDrug
Also called Neurontin
gabapentin 1200mg/day for 12 weeks
PlaceboDrug
1200mg/day of placebo for 12 weeks
Manual-guided behavioral counselingBehavioural
Also called Manual-guided therapy
Standardized manual-guided behavioral counseling performed 1 time per week for 12 weeks in conjunction with study drug or placebo.
| Study group | Role | What they receive |
|---|---|---|
| Gabapentin 1200mg/day | Experimental | 1200mg/day of gabapentin for 12 weeks given in conjunction with 12 weeks of manual-guided behavioral counseling. Receives: Drug: gabapentin 1200mg/day; Behavioral: Manual-guided behavioral counseling |
| Placebo | Placebo comparator | 1200mg/day of placebo for 12 weeks given in conjunction with 12 weeks of manual-guided behavioral counseling. Receives: Drug: Placebo; Behavioral: Manual-guided behavioral counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Negative Urinary Drug Screens (UDS) for Cannabis at 12 Weeks Following Administration of Gabapentin or Placebo During the Double Blind Period
Express Results Integrated Multi-Drug Screen Cups were used to obtain a semi-quantitative urine drug screen for delta-9-THC. Submitted UDS would yield a positive result when the concentration of THC-COOH in urine exceeded 50 ng/mL. Specimens were collected weekly. Two analytical approaches were used: one where any missed UDS test was assumed positive (i.e intent-to-treat (ITT)) and another where missed UDS were considered missing at random (MAR).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2009 (estimated)
- Study start4 Nov 2009
- Primary completion19 May 2016
- Study completion19 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cannabis DependenceStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Scripps Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Barbara J. Mason, The Scripps Research Institute
- Investigators
- Barbara J Mason, Ph.D., Principal investigator, The Scripps Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00974376
- Sponsor's protocol ID
- DA026758
- Other IDs
- 5R01DA026758-05
- Status last verified
- May 2017
- First submitted
- 1 Sep 2009
- Last updated
- 6 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gabapentin Treatment of Cannabis Dependence
- ClinicalTrials.gov ID
- NCT00974376
- Acronym / sponsor ID
- DA026758
- Conditions
- Cannabis Dependence, Cannabis Withdrawal, Cognitive Deficits
- Keywords
- Cannabis Treatment, Cannabis Use, Cannabis Dependence, Executive Functioning, Cognitive Deficits
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- The Scripps Research InstituteUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 4 Nov 2009 (actual)
- Primary completion
- 19 May 2016 (actual)
- Study completion
- 19 May 2016 (actual)
- First posted
- 10 Sep 2009 (estimated)
- Results
- Posted 6 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a clinical study to evaluate the efficacy of the medication gabapentin in treating persons with cannabis dependence.
Detailed description
This is a 12-week, double blind, placebo controlled study to evaluate the efficacy of gabapentin in treating outpatients with cannabis dependence. After an initial phone screen, a comprehensive screening visit is scheduled to determine eligibility. Upon enrollment, counseling, medication dispensation and research assessments occur 1 time per week for 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gabapentin 1200mg/day | Experimental | Drug: gabapentin 1200mg/day, Behavioral: Manual-guided behavioral counseling1200mg/day of gabapentin for 12 weeks given in conjunction with 12 weeks of manual-guided behavioral counseling. |
| Placebo | Placebo comparator | Drug: Placebo, Behavioral: Manual-guided behavioral counseling1200mg/day of placebo for 12 weeks given in conjunction with 12 weeks of manual-guided behavioral counseling. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males or females from 18-65 years of age
- Meets DSM IV criteria for current cannabis dependence
- Seeking research-based outpatient treatment for cannabis dependence that involves daily medication
- Smoked MJ daily at least 25 days per month during the 90 days prior to randomization
- At least a 2-year history of regular MJ use
Key exclusion criteria (10 listed)
- Abstinent from cannabis more than 2 days at the time of randomization
- Active suicidal ideation
- Currently meets DSM IV criteria for abuse or dependence on other substances, or has urine drug screen positive for substances, other than cannabis or nicotine
- Significant medical disorders that will increase potential risk or interfere with study participation,
- Sexually active female participants with childbearing potential who are pregnant, nursing or refuse to use a reliable method of birth control
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 |
|---|---|---|
| gabapentin 1200mg/dayAlso: Neurontingabapentin 1200mg/day for 12 weeks | Drug | Gabapentin 1200mg/day |
| Placebo1200mg/day of placebo for 12 weeks | Drug | Placebo |
| Manual-guided behavioral counselingAlso: Manual-guided therapyStandardized manual-guided behavioral counseling performed 1 time per week for 12 weeks in conjunction with study drug or placebo. | Behavioural | Gabapentin 1200mg/day, Placebo |
Primary outcome
Percentage of Negative Urinary Drug Screens (UDS) for Cannabis at 12 Weeks Following Administration of Gabapentin or Placebo During the Double Blind Period
Time frame: 12 weeks
Express Results Integrated Multi-Drug Screen Cups were used to obtain a semi-quantitative urine drug screen for delta-9-THC. Submitted UDS would yield a positive result when the concentration of THC-COOH in urine exceeded 50 ng/mL. Specimens were collected weekly. Two analytical approaches were used: one where any missed UDS test was assumed positive (i.e intent-to-treat (ITT)) and another where missed UDS were considered missing at random (MAR).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Study WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Barbara J Mason, Ph.D. principal investigator
The Scripps Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing gabapentin 1200mg/day and Manual-guided behavioral counseling in people with Cannabis Dependence and Cannabis Withdrawal, run by The Scripps Research Institute at 1 site in United States.
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 5 inclusion and 10 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: finished, as of the sponsor's last update on 6 Jun 2017. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Negative Urinary Drug Screens (UDS) for Cannabis at 12 Weeks Following Administration of Gabapentin or Placebo During the Double Blind Period (time frame: 12 weeks). 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 6 Jun 2017.