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The purpose of this study is assess Sativex as a treatment for Cannabis dependence. Initially a pilot study will be conducted in five subjects seeking treatment for cannabis dependence to ensure that our planned self-titration regimen is appropriate using Sativex. This phase will be open label, with no placebo control. Then, there will be a twelve-week, double-blind, placebo-controlled study in male and female subjects seeking treatment for cannabis dependence (n=40). All participants will receive a combination of pharmacotherapy (Sativex Spray or Placebo Spray) associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy (MET/CBT). The subjects will have to come daily to the centre to assess usage of medication. Following the medication phase, participants will have a follow-up weekly for another four weeks and then monthly until the 6 month follow up visit after the target quit date. The investigators are planning to enroll 45 subjects over the two-year period.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2017-10-02
What this record can show
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
Registry facts
In the pilot study subjects will be treated with SATIVEX® (THC/cannabidiol combination in a buccal spray) using the same approach as outlined below for the randomized controlled trial. In the twelve-week, double-blind, placebo-controlled study visits will occur weekly during the medication phase of the study. The medication will be self-titrated over three weeks and a target quit date will be set up at Day 21. There will be a total of 12 weeks of drug exposure. Throughout these 12-weeks, all participants will receive a combination of pharmacotherapy (Sativex Spray or Placebo Spray) associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy (MET/CBT) in accordance with the intervention practices shown to be effective in treatment of cannabis dependence. The intervention will be adapted from the Brief Counselling for Marijuana Dependence manual published by the Substance Abuse and Mental Health Services Administration (SAMHSA). At each study visit, vital signs and self-report ratings will be collected. In addition, the subjects will have to come daily to the centre to assess medication usage and will be asked to provide urine sample (two times weekly) and blood sample weekly. As there may be compliance issues, a contingency management approach will be also implemented.
Linked local records
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Interventions
All participants will receive a combination of pharmacotherapy (Sativex or Placebo) associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy.
Study subjects will gradually increase the maximal allowed dose of Sativex starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays maximal per day at end of week 2 (Day 11). The target quit date will be set at Day 21 (but subjects will be allowed to stop using cannabis before if they are willing and able to). The medication treatment phase will then be continued for an additional 9 weeks (the last week will be a reduction phase with the use of Spray that will be decreased by 50% to avoid abrupt withdrawal). Then exposure to medications will be stopped (so there will be a total of 12 weeks medication treatment exposure).
delta-9-tetrahydrocannabinol and cannabidiolStudy subjects will gradually increase the maximal allowed dose of Placebo starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays maximal per day at end of week 2 (Day 11). The target quit date will be set at Day 21 (but subjects will be allowed to stop using cannabis before if they are willing and able to). The Placebo treatment phase will then be continued for an additional 9 weeks (the last week will be a reduction phase with the use of Placebo Spray that will be decreased by 50%). Then exposure to Placebo will be stopped (so there will be a total of 12 weeks Placebo treatment exposure).
Ethanol,propylene glycol,and peppermint oil with colorsSource-reported results
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
Assessment of tolerability will be determined by the number of subjects that withdrawal from the study due to SAEs.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Sativex # of Participants That Withdrew Due SAE | 20 | 0 | - |
| Placebo # of Participants That Withdrew Due SAE | 20 | 0 | - |
| Pilot Study # of Participants That Withdrew Due SAE | 5 | 0 | - |
The percentage of days that participants self-reported use of cannabis over the study duration until 6 month follow-up will be assessed (i.e. smoking diary self-report)
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Sativex % Days Use of Cannabis | 20 | 42.9 | 7.7 |
| Placebo % Days Use of Cannabis | 20 | 47.1 | 12.9 |
| Pilot % Days Use of Cannabis | 5 | 48.3 | 22.5 |
Effect of Sativex on withdrawal symptom scores will be assessed using the Marijuana Withdrawal Checklist (MWC). Average Total score for the trial (6 months) is reported. Range 0 - 46. Higher scores indicate more severe symptoms associated with marijuana withdrawal.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Sativex Withdrawal | 20 | 5.0 | 4.7 |
| Placebo Withdrawal | 20 | 5.1 | 3.9 |
| Pilot Withdrawal | 5 | 2.7 | 2.5 |
Effect of Sativex on cannabis craving will be assessed using the Marijuana Craving Questionnaire (MCQ). Average Total score for the trial (6 months) is reported. Participants rate the 12 items using a 7-item Likert scale ranging from strongly disagree to strongly agree, and the total score ranges from 4 to 28 (subscales compulsivity (mean items 2, 7 and 10), emotionality (mean items 4, 6 and 9), expectancy (mean items 5, 11 and 12) and purposefulness (mean items 1, 3 and 8); total score is the sum for the 4 subscales). Higher scores indicate more severe craving for marijuana.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Sativex Craving | 20 | 8.2 | 4.3 |
| Placebo Craving | 20 | 9.6 | 5.7 |
| Pilot Craving | 5 | 9.5 | 5.2 |
Amount of cannabis used in grams over the study duration until 6 month follow-up will be assessed
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Sativex Cannabis Use (g) | 20 | 2.3 | 0.76 |
| Placebo Cannabis Use (g) | 20 | 3.5 | 1.26 |
| Pilot Cannabis Use (g) | 5 | 1.6 | 1.48 |
| Milestone | Pilot Study | Sativex | Placebo Spray |
|---|---|---|---|
| STARTED | 5 | 20 | 20 |
| COMPLETED | 4 | 13 | 14 |
| NOT COMPLETED | 1 | 7 | 6 |
| Event | System | Groups: affected / at risk |
|---|---|---|
| Insomnia | Nervous system disorders | Sativex: 11 / 20 · Placebo Spray: 8 / 20 · Pilot Study: 3 / 5 |
| Headache | Vascular disorders | Sativex: 4 / 20 · Placebo Spray: 10 / 20 · Pilot Study: 3 / 5 |
| Oro Mucal | Gastrointestinal disorders | Sativex: 2 / 20 · Placebo Spray: 2 / 20 · Pilot Study: 2 / 5 |
| Cold/Influenza | Respiratory, thoracic and mediastinal disorders | Sativex: 4 / 20 · Placebo Spray: 6 / 20 · Pilot Study: 3 / 5 |
| Cardiovascular | Cardiac disorders | Sativex: 0 / 20 · Placebo Spray: 2 / 20 · Pilot Study: 0 / 5 |
| Nightmare | General disorders | Sativex: 0 / 20 · Placebo Spray: 2 / 20 · Pilot Study: 1 / 5 |
| Diarrhea | Gastrointestinal disorders | Sativex: 2 / 20 · Placebo Spray: 4 / 20 · Pilot Study: 1 / 5 |
| Pain | Musculoskeletal and connective tissue disorders | Sativex: 0 / 20 · Placebo Spray: 2 / 20 · Pilot Study: 2 / 5 |
| Mood Disturbance | Psychiatric disorders | Sativex: 2 / 20 · Placebo Spray: 0 / 20 · Pilot Study: 1 / 5 |
| Decrease in Libido | Psychiatric disorders | Sativex: 0 / 20 · Placebo Spray: 3 / 20 · Pilot Study: 0 / 5 |
| Decreased appetite | General disorders | Sativex: 2 / 20 · Placebo Spray: 2 / 20 · Pilot Study: 1 / 5 |
| Nausea | Gastrointestinal disorders | Sativex: 2 / 20 · Placebo Spray: 6 / 20 · Pilot Study: 2 / 5 |
| Urinary Problems | Renal and urinary disorders | Sativex: 2 / 20 · Placebo Spray: 0 / 20 · Pilot Study: 0 / 5 |
| Constipation | Gastrointestinal disorders | Sativex: 0 / 20 · Placebo Spray: 2 / 20 · Pilot Study: 1 / 5 |
| Skin rashes | Skin and subcutaneous tissue disorders |
Eligibility
primary outcomes
Time frame: six months
Assessment of tolerability will be determined by the number of subjects that withdrawal from the study due to SAEs.
secondary outcomes
Time frame: six months
The percentage of days that participants self-reported use of cannabis over the study duration until 6 month follow-up will be assessed (i.e. smoking diary self-report)
Time frame: six months
Effect of Sativex on withdrawal symptom scores will be assessed using the Marijuana Withdrawal Checklist (MWC). Average Total score for the trial (6 months) is reported. Range 0 - 46. Higher scores indicate more severe symptoms associated with marijuana withdrawal.
Time frame: six months
Effect of Sativex on cannabis craving will be assessed using the Marijuana Craving Questionnaire (MCQ). Average Total score for the trial (6 months) is reported. Participants rate the 12 items using a 7-item Likert scale ranging from strongly disagree to strongly agree, and the total score ranges from 4 to 28 (subscales compulsivity (mean items 2, 7 and 10), emotionality (mean items 4, 6 and 9), expectancy (mean items 5, 11 and 12) and purposefulness (mean items 1, 3 and 8); total score is the sum for the 4 subscales). Higher scores indicate more severe craving for marijuana.
Time frame: six months
Amount of cannabis used in grams over the study duration until 6 month follow-up will be assessed
Publications
No exact PMID-linked public article is currently readable locally.
| Sativex: 0 / 20 · Placebo Spray: 0 / 20 · Pilot Study: 1 / 5 |
| Indigestion | Gastrointestinal disorders | Sativex: 0 / 20 · Placebo Spray: 0 / 20 · Pilot Study: 1 / 5 |
| Light Headedness | Cardiac disorders | Sativex: 0 / 20 · Placebo Spray: 0 / 20 · Pilot Study: 1 / 5 |
| excessive sweating | Nervous system disorders | Sativex: 0 / 20 · Placebo Spray: 2 / 20 · Pilot Study: 1 / 5 |
| Ringing in ears | General disorders | Sativex: 2 / 20 · Placebo Spray: 0 / 20 · Pilot Study: 1 / 5 |
| Walking up in the middle of night | Psychiatric disorders | Sativex: 0 / 20 · Placebo Spray: 0 / 20 · Pilot Study: 1 / 5 |
| Tiredness | General disorders | Sativex: 0 / 20 · Placebo Spray: 0 / 20 · Pilot Study: 2 / 5 |